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Journal articles on the topic 'LC–MS/MS Method Validation Piribedil Human plasma Bioanalytical Pharmacokinetic study Bioequivalence'

Author: Grafiati

Published: 5 June 2025

Last updated: 1 August 2025

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1

Alshishani, Anas, Inas Hasan, Fatima Ghanayem, Sewar Al-khasawneh, and Dayah Alaa Abu. "Simple and rapid LC-MS/MS method for determination of Piribedil in human plasma." Pharmacia 69, no. (3) (2022): 615–20. https://doi.org/10.3897/pharmacia.63.e86447.

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A sensitive, simple, and fast LC-MS/MS method of analysis was developed and validated for the determination of piribedil in human plasma. Piribedil was extracted by protein precipitation using acetonitrile and separated on C18 Phenomenex Gemini column (150 × 4.6mm, 5 µm) using isocratic elution of 75% of ammonium acetate buffer (10 mM) and 25% acetonitrile at a flow rate of 1 ml.min-1 over 5 min run time. Piribedil and d8-Piribedil, as internal standard, were detected and quantified in positive ion mode via MRM at m/z 299/135 and 307/135 for piribedil and d8–piribedil, respectively. The sugges

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Rahul, Patil* Rajveer Bhaskar Monika Ola Diksha Pingale Shailesh Chalikwar. "BIOANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION IN HUMAN PLASMA BY USING LC MS/MS." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 03 (2019): 5176–83. https://doi.org/10.5281/zenodo.2591534.

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<em>Bioanalytical method development plays importance role in the pre-clinical and clinical studies. Pharmacokinetics of any drug and its metabolite can be recognized by bioanalytical studies. The quantitative analysis of drugs and their metabolite sin the biological media is done by bioanalytical studies. Physical-chemical and biological techniques are used for these studies. Every bioanalytical method should be selective, sensitive and reliable for the quantitative estimation in drug discovery process. Bioanalytical method development consists of sample preparation, chromatographic separatio

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Kit Loh, Gabriel Onn, Emily Yii Ling Wong, Yvonne Tze Fung Tan, et al. "Simultaneous determination of duloxetine and 4-hydroxy duloxetine glucuronide in human plasma and back-conversion study." Bioanalysis 13, no. 22 (2021): 1681–96. http://dx.doi.org/10.4155/bio-2021-0185.

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Aim: To develop an LC-MS/MS method for simultaneous determination of duloxetine and its metabolite, 4-hydroxy duloxetine glucuronide (4HDG) in human plasma and to investigate the potential back-conversion of 4HDG to duloxetine using stability study. Materials & methods: The LC-MS/MS method was validated according to the EMA and USFDA Bioanalytical Method Validation Guidelines and applied to pilot bioequivalence study. Results & conclusion: The method validation results were within the acceptance limits. The stability study and incurred sample reanalysis results ruled out the occurrence

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Tijare, Lokesh Khushalrao, Rangari Nt, and Mahajan Un. "A REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION." Asian Journal of Pharmaceutical and Clinical Research 9, no. 9 (2016): 6. http://dx.doi.org/10.22159/ajpcr.2016.v9s3.14321.

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ABSTRACTIn this review article, bioanalytical methods are widely used to quantitate drugs and their metabolites in plasma matrices and the methods should beapplied to studies in areas of human clinical and nonhuman study. Bioanalytical method employed for the quantitative estimation of drugs and theirmetabolites in biological media and plays an important role in estimation and interpretation of bioequivalence, pharmacokinetic, and toxicokineticstudies. The major bioanalytical role is method development, method validation, and sample analysis. Every step in the method must be investigatedto dec

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Bose, R., S. Dan, P. Mandal, et al. "BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF MICRONIZED GLICLAZIDE IN HUMAN PLASMA BY LC-MS/MS AND ITS PHARMACOKINETIC STUDIES." INDIAN DRUGS 55, no. 09 (2018): 24–33. http://dx.doi.org/10.53879/id.55.09.11405.

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Drugs having poor oral bioavailability, fail to reach the minimum effective concentration required to achieve pharmacological action. Improvement of the oral bioavailability of the drug is the most realistic approach, as it is the most preferred and convenient route of administration. Besides numerous techniques to improve oral bioavailability of the drugs, particle size reduction leads to increase in the effective surface area, resulting in enhancement of solubility and dissolution velocity of the drug. In the present study a sustained release tablet formulation containing 60mg micronized gli

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Raslan, Mohamed, Eslam Mansour Shehata, Sara A. R., and Nagwa A. Sabri. "Simultaneous Determination of Ledipasvir/Sofosbuvir by LC/MS/MS in Human Plasma and its Pharmacokinetics Application." Saudi Journal of Medical and Pharmaceutical Sciences 8, no. 5 (2022): 214–26. http://dx.doi.org/10.36348/sjmps.2022.v08i05.001.

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Background: The rapid growth of COVID-19 infections may result in second wave of infection and an overwhelmed health care providing systems. Ledipasvir and sofosbuvir can be a good choice for management of COVID-19 patients. Development of simple, sensitive, and rapid assay for simultaneous determination of ledipasvir / sofosbuvir to investigate their pharmacokinetic parameters in human plasma, and aid in therapeutic drug moitoring in COVID-19 patients seems to be essential. Besides, its application in bioequivalence study of ledipasvir 90mg / sofosbuvir 400mg film coated tablets generic and r

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Neha, Gaikwad* Kanchan Shinde Varsha Pangale Charushila Bhangale. "Bioanalytical Method Development And Validation For The Estimation Of Active Pharmaceuticals In Dosage Forms." Int. J. in Pharm. Sci. 1, no. 2 (2023): 143–52. https://doi.org/10.5281/zenodo.7755584.

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In this review article, bioanalytical techniques are often employed to quantify pharmaceuticals and their metabolites in plasma matrices, and the techniques should be used in both human clinical investigations and nonhuman research. A key component of estimate and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic investigations is the use of the bioanalytical technique for the quantitative measurement of medicines and their metabolites in biological medium. Method creation, method validation, and sample analysis are the three main responsibilities of bioanalysis. To determin

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Bouchafra, Houda, Aimen El Orche, Choukri El Khabbaz, et al. "Determination and validation of tiaprofenic acid in human plasma: A detailed LC-MS/MS-based analysis following ICH M10 guidelines and the accuracy profile approach." Current Chemistry Letters 13, no. 4 (2024): 707–16. http://dx.doi.org/10.5267/j.ccl.2024.4.003.

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The validation of bioanalytical methods holds critical importance for regulatory agencies and organizations dedicated to ensuring the safety, efficacy, and quality of pharmaceuticals. In this context, the recent release of the ICH M10 guideline in May 2022 represents a significant milestone in standardizing bioanalytical method validation globally. However, this guideline lacks explicit experimental protocols for implementation. In this study, we address the practical implementation of the newly released ICH M10 guideline by providing a detailed validation protocol for a bioanalytical method.

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El Orche, Aimen, Amine Cheikh, Choukri El Khabbaz, et al. "Advancing Bioanalytical Method Validation: A Comprehensive ICH M10 Approach for Validating LC–MS/MS to Quantify Fluoxetine in Human Plasma and Its Application in Pharmacokinetic Studies." Molecules 29, no. 19 (2024): 4588. http://dx.doi.org/10.3390/molecules29194588.

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A fast and sample cleanup approach for fluoxetine in human plasma was developed using protein precipitation coupled with LC–MS-MS. Samples were treated with methanol prior to LC–MS-MS analysis. Chromatographic separation was performed on a reverse phase column with an isocratic mobile phase of methanol and 10 mM ammonium formate pH acidified with formic acid (80:20, v/v) at a flow rate of 0.2 mL/min. The run time was 4 min. Mass parameters were optimized to monitor transitions at m/z [M + H]+ 310 > > 148 for fluoxetine and m/z [M + H]+ 315.1 > > 153 for fluoxetine-d5 as an internal

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Halder, Dhiman, Shubhasis Dan, Pradipta Sarkar, Dibya Das, Umesh Chandra Halder, and Tapan Kumar Pal. "LC-MS/MS determination of 4-hydroxynimesulide, an active metabolite of nimesulide and application to bioequivalence study in Indian subjects." European Journal of Mass Spectrometry 25, no. 5 (2019): 399–411. http://dx.doi.org/10.1177/1469066718822621.

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A simple and highly sensitive bioanalytical method was developed and validated for simultaneous quantification of nimesulide (NSD) and its active metabolite 4-hydroxy-nimesulide (M1) in human plasma by liquid chromatography-tandem mass spectrometer (LC-MS/MS) and applied in a bioequivalence study performed on Indian subjects. The bioanalytical method was carried out by LC-MS/MS with celecoxib (CXB) as an internal standard (IS) using liquid–liquid extraction technique. The chromatographic separation was performed on a reversed-phase Agilent eclipse plus C18 (75 mm × 4.6 mm, particle size 3.5 µm

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Raslan, Mohamed, Eslam M. S., Sara A. R, and Nagwa A. Sabri. "Determination of Vardenafil in Human Plasma by LC/MS/MS and its Clinical Applications." Saudi Journal of Medical and Pharmaceutical Sciences 8, no. 2 (2022): 53–61. http://dx.doi.org/10.36348/sjmps.2022.v08i02.003.

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Background: Sexual dysfunction as a result of the inability to achieve or maintain an erection is a common problem that increases with age. Vardenafil has shown results as an efficacious and safe therapeutic agent for treatment of erectile dysfunction. AIM: Development of a bio-analytical method for rapid quantification of vardenafil in biological fluids and its application in pharmacokinetics and bioavailability studies, clinical trials, and monitor its therapeutic levels to help attaining effective clinical results in treating erectile dysfunction. Methods: Vardenafil was extracted from plas

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Farooq, Jagirdar Sikandar Zoolquernain, and Furquan Nazimuddin Khan. "QbD-Driven Development and Validation of a Bioanalytical LC–MS Method for Quantification of Paliperidone in Human Plasma." International Journal of Experimental Research and Review 36 (December 30, 2023): 47–57. http://dx.doi.org/10.52756/ijerr.2023.v36.004.

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This paper discusses how a Quality by Design (QbD) strategy was used to develop and test an HPLC-MS bioanalytical method for detecting plasma Paliperidone concentration. A C18 column and an isocratic mobile phase of organic solvents and water were improved for chromatographic separation. To optimise method performance, Box-Behnken design was used to study column temperature, mobile phase composition, and flow rate. The research used a logical QbD methodology to build an optimised HPLC-MS technology that meets US-FDA standards. Validation studies evaluated selectivity, sensitivity, carryover ef

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Liu, Shuxia, Yuanyuan Song, Di Wu, Lin Lin, Yuankai Shi, and Xiaohong Han. "A validated ultra-performance LC–MS/MS method for quantifying a novel oral EGFR inhibitor FCN-411 in human plasma." Bioanalysis 12, no. 5 (2020): 295–304. http://dx.doi.org/10.4155/bio-2019-0290.

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Aim: To investigate the clinical pharmacokinetic profiles of FCN-411, a new EGFR tyrosine kinase inhibitor, an ultra-performance LC–MS/MS method was developed. Methods & results: The method was suitable to determine FCN-411 in plasma due to the fast sample preparation (protein precipitation procedure), a good linear range of 2–500 ng/ml, low amount of sample volume (5 μl) and less run time (4.5 min) for analysis. And it was demonstrated to be acceptable according to the guidelines for bioanalytical assay validation. Conclusion: The method was robust, sensitive and repeatable, and it is rea

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Benoist, Mette, Eric van der Meulen, Inge Van Oort, et al. "Development and validation of a bioanalytical assay on LC/MS/MS to quantify enzalutamide and N-desmethylenzalutamide in human plasma." Journal of Clinical Oncology 34, no. 2_suppl (2016): 330. http://dx.doi.org/10.1200/jco.2016.34.2_suppl.330.

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330 Background: To study the relation between drug exposure and therapeutic effect of enzalutamide and its equipotent metabolite N-desmethylenzalutamide, a bioanalytical assay on liquid chromatography tandem mass spectrometry (LC-MS/MS) was developed and validated to determine plasma concentrations in vivo. Methods: Plasma samples were diluted 10-fold with 20% albumin solution. Protein precipitation with acetonitrile was used to pretreat the diluted plasma. A stable isotope (D6-enzalutamide) was used as the internal standard. During validation five quality controls were used (LLOQ, LQ, MQ, HQ,

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15

Gnanasekaran, D., and R. Gandhimathi. "A QbD Assisted Bioanalytical Method Development and Validation for Simultaneous Estimation of Montelukast and Bilastine by LC-MS Technique." INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 14, no. 04 (2023): 1100–1106. http://dx.doi.org/10.25258/ijpqa.14.4.44.

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This study describes how to use internal standards (IS) under the Analytical Quality by Design (AQbD) methodology to measure montelukast and bilastine in artificial rabbit plasma. The protein precipitation method was used for sample preparation and extraction. The chromatographic analysis was performed on the processed materials. The measurement range of the calibration was between 2 to 40 ng/mL for Bilastine and 1 to 20 ng/mL for montelukast. Optimizing mobile phase composition, flow rate, and pH were used to determine peak area and retention time. A significant reduction in method variabilit

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Farooq, Jagirdar SZ, and Furquan N. Khan. "Ranolazine Quantification in Human Plasma: A QbD-Guided LC-MS Method Development and Validation." INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 14, no. 04 (2023): 882–87. http://dx.doi.org/10.25258/ijpqa.14.4.10.

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The present research outlines a comprehensive and systematic approach for the development and validation of a bioanalytical Liquid chromatography–mass spectrometry (LC-MS) method to quantify ranolazine in human plasma. The study employs principles of quality by design (QbD) to enhance method robustness, precision, and accuracy. The primary goals of this research were to create a reliable LC-MS method for the accurate quantification of ranolazine in human plasma and to validate this approach in accordance with established standards set by regulatory bodies. A secondary objective was to explore

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Malviya, Jitendra, Deshbandhu Joshi, and Raghvendra Singh Bhadauria. "Bioanalytical method Development and Validation for Estimation of Olanzapine in K3edta Human Plasma by Liquid Chromatography–Tandem Mass Spectrometry and Application to a Pharmacokinetic Study." International Journal of Medical Science and Clinical Invention 9, no. 04 (2022): 6046–55. http://dx.doi.org/10.18535/ijmsci/v9i04.03.

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A rapid and sensitive LC–MS/MS method for the bioanalytical method development and validation for estimation of olanzapine in k3EDTA human plasma using Olanzapine D3 as internal standard has been developed and validated. The analytes and IS were extracted from plasma by solid phase extraction using Oasis HLB 1cc (30mg) Extraction Cartridge and separated on a Cosmosil, 5µm, C18 150*4. 6 mmcolumn using a 10 mM ammonium formate in Water: Acetonitrile (10: 90) at a flow rate of 1.0 mL/min. Detection involved an API-4000 LC–MS/MS with electrospray ionization in the positive ion mode and multiple-re

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Konda, Ravi Kumar, B. R. Challa, Babu Rao Chandu, and Kothapalli B. Chandrasekhar. "Bioanalytical Method Development and Validation of Memantine in Human Plasma by High Performance Liquid Chromatography with Tandem Mass Spectrometry: Application to Bioequivalence Study." Journal of Analytical Methods in Chemistry 2012 (2012): 1–8. http://dx.doi.org/10.1155/2012/101249.

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A simple, sensitive, and rapid HPLC-MS/MS method was developed and validated for quantitative estimation of memantine in human plasma. Chromatography was performed on Zorbax SB-C18(4.6×75 mm, 3.5 μm) column. Memantine (ME) and internal standard Memantine-d6(MED6) were extracted by using liquid-liquid extraction and analyzed by LC-ESI-MS/MS using multiple-reaction monitoring (MRM) mode. The assay exhibited a linear dynamic range of 50.00–50000.00 pg/ml for ME in human plasma. This method demonstrated an intra- and interday precision within the range of 2.1–3.7 and 1.4–7.8%, respectively. Furthe

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Dr.M.Sumithra, Dr M. Sumithra, Akshaya B. Akshaya.B, and M. Vijey Aanandhi. "Determination of Alendronate in Human Plasma By using UltraPerformance Liquid Chromatography-Mass Spectrometry/ Mass Spectrometry." International Journal of Pharmaceutical Research and Applications 09, no. 06 (2024): 1112–21. https://doi.org/10.35629/4494-090611121121.

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INTRODUCTION The process of determining if a quantitative analytical method is adequate for biochemical applications is known as bioanalytical method validation (BMV).Alendronate is a medication that is used to prevent and treat osteoporosis in humans. Osteoporosis causes bones to shrink and fracture more easily. Osteoporosis is more likely to develop as you become older, after menopause, or if you use corticosteroid drugs (such as prednisone) for a long time. The aim of our work is to develop a validated method for the determination of Alendronate in plasma by using LC-MS/MS. MATERIALS AND ME

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Hima Bindu, M., and Gubbiyappa Shiva Kumar. "Development and Validation of Bioanalytical Method for the Quantification of Febuxostat in Human K2 EDTA Plasma by LC-MS/MS: Pharmacokinetic Studies in Wister Rats." Asian Journal of Chemistry 35, no. 8 (2023): 2015–20. http://dx.doi.org/10.14233/ajchem.2023.28162.

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A specific, linear and accurate LC-MS/MS method was developed for the determination of febuxostat in human K2 EDTA plasma and it was successfully applied for the pharmacokinetic study in wister rats. Chromatographic isolation of febuxostat and febuxostat D9 were attained on Purosphur C18, 100 × 4.6 mm, 5 μ column with 1.0 mL/min flowing rate. The technique was linear over the standard concentrations ranging from 24.995-7001.401 ng/mL and the regression coefficient was perceived to be ≥ 0.9997. All LLOQ samples % RSD of back computed concentrations varied from 1.00 to 4.01. The analysis of plas

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Zhang, Xueyuan, Yuhuan Ji, Jinzhi Liu, et al. "Regulated bioanalysis of liposomal amphotericin B to support pharmacokinetic studies of liposomal drugs." Bioanalysis 14, no. 7 (2022): 421–39. http://dx.doi.org/10.4155/bio-2021-0281.

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Background: Because of the delicate nature of liposomes, bioanalysis of free and liposomal-encapsulated drugs is among the most challenging assays to perform. Current regulatory guidance for bioanalysis is not sufficient to address the complexity of this particular formulation. Method & results: Three individual LC–MS/MS methods to quantify free amphotericin B (10–3000 ng/ml) and encapsulated amphotericin B (100–50,000 ng/ml) in pretreated human plasma and total amphotericin B (100–50,000 ng/ml) in human plasma were fully validated and applied to a bioequivalence study. The acceptance crit

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Lee, Sangyoung, Da Hyun Kim, Sabin Shin, et al. "Development and Validation of Bioanalytical LC–MS/MS Method for Pharmacokinetic Assessment of Amoxicillin and Clavulanate in Human Plasma." Pharmaceuticals 18, no. 7 (2025): 998. https://doi.org/10.3390/ph18070998.

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Background/Objectives: We developed and validated a robust and simple LC–MS/MS method for the simultaneous quantification of amoxicillin and clavulanate in human plasma relative to previously reported methods. Methods: Amoxicillin; clavulanate; and an internal standard, 4-hydroxytolbutamide, in human K2-EDTA plasma, were deproteinized with acetonitrile and then subjected to back-extraction using distilled water–dichloromethane. Separation was performed on a Poroshell 120 EC-C18 column with a mobile-phase gradient comprising 0.1% aqueous formic acid and acetonitrile at a flow rate of 0.5 mL/min

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Iram, Rashid Gore* Swati Wakchoure¹ Dhanashree Kathole Dev Gaikwad Nishita Hole. "Documentation of Liquid Chromatography-Mass Spectrometry (LC-MS) Technique for Quantitative Analysis of Naproxen in Human Plasma." International Journal of Pharmaceutical Sciences 2, no. 12 (2024): 3064–72. https://doi.org/10.5281/zenodo.14551254.

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Naproxen is a commonly used non steroidal anti-inflammatory drug (NSAID) employed in treatment of pain, fever and inflammation. It has the ability to bind and inhibit synthesis of prostaglandins and produces anti inflammatory effect. Accurate quantification of naproxen in human plasma is essential for bioavailability, pharmacokinetic and clinical studies. Liquid chromatography -Mass Spectrometry has emerged as a gold standard analytical approach for such purpose due to its good sensitivity, specificity and rapid analysis. A quick and selective LC-MS approach for quantification of naproxen in h

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Mandal, P., S. Dan, B. Ghosh, S. Barma, R. Bose, and T. K. Pal. "SIMULTANEOUS DETERMINATION AND QUANTITATION OF METFORMIN AND TENELIGLIPTIN IN HUMAN PLASMA BY LC-ESI-MS/MS WITH AN APPLICATION TO PHARMACOKINETIC STUDIES." INDIAN DRUGS 55, no. 04 (2018): 28–38. http://dx.doi.org/10.53879/id.55.04.11242.

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‘Gliptins’ is the nickname given to a group of anti-diabetic medicines-DPP-4 inhibitors, such as sitagliptin, vildagliptin, sexagliptin, linagliptin, alogliptin and teneligliptin, which are used with metformin for combination therapy of type 2 diabetes mellitus. Advantages of this combined therapy are low risks of hypoglycemia and weight gain compared with other classes of anti-diabetic drugs. In the present study efforts, were made to develop and validate a bioanalytical method for simultaneous estimation of metformin and teneligliptin in human plasma by LC-MS/MS with an application to quanti

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Marella, Vijaya Lakshmi, Mohan Gandhi Bonthu, Suneetha Achanti, Harshini Kasula, and Sarala Nekkalapudi. "LC-MS/MS Bioanalytical Approach for the Quantitative Analysis of Dabigatran in Biological Fluids." Asian Journal of Chemistry 35, no. 12 (2023): 2987–91. http://dx.doi.org/10.14233/ajchem.2023.30318.

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A novel bioanalytical methodology has been developed to establish a rapid and sensitive procedure for the detection of dabigatran in biological fluid, specifically human plasma. In this study, dabigatran 13C6 was utilized as an internal standard (IS). The solid phase extraction method was employed to extract dabigatran and internal standard (IS) from a plasma sample. The separated components are determined by utilizing a eluting mixture composed of 2 mM ammonium formate:methanol:acetonitrile (20:40:40 v/v/v). The procedure utilized a GL Sciences Ace C18 stationary phase with dimensions of 150

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Nair, Sheeba, Bhavesh Dasandi, Dharmesh Parmar, ,. Shivprakash, and Denish Karia. "Sensitive and Rapid determination of Trientine and N1-Acetyl Trientine in Human Plasma by LC-MS/MS for bioequivalence study." Journal of Drug Delivery and Therapeutics 9, no. 3 (2019): 310–18. http://dx.doi.org/10.22270/jddt.v9i3.2660.

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A simple and robust method for simultaneous determination of Trientine and N1-Acetyl Trientine in human plasma by liquid chromatography-tandem mass spectrometry (LC-MS/MS) was developed and validated. The analyte and internal standard were extracted from 200 μL plasma by liquid phase extraction. Chromatographic analysis was carried out on column Xtimate, C18 (4.6 x 50 mm) 5 μm with a flow rate of 1 mL/min, at 40˚C temperature. An isocratic elution method was applied using (A) Acetonitrile - 80% and (B) 10mM Ammonium Acetate in water - 20%. Detection and quantitation was done by multiple reacti

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Haque, Anzarul, Muzaffar Iqbal, Mariam K. Alamoudi, and Prawez Alam. "A Selective and Accurate LC-MS/MS Method for Simultaneous Quantification of Valsartan and Hydrochlorothiazide in Human Plasma." Separations 10, no. 2 (2023): 119. http://dx.doi.org/10.3390/separations10020119.

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The fixed dose combination of valsartan (VAL) and hydrochlorothiazide (HCTZ) is the most commonly prescribed medicine for the effective treatment of hypertension. In this study, a simple sensitive and accurate liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed for the simultaneous quantitation of VAL and HCTZ in human plasma by using irbesartan (IRB) and hydroflumethiazide (HFMZ) as their specific internal standards (ISs). HLB cartridge-based solid-phase extraction was used for the extraction of analytes and ISs. The chromatographic separation was achieved on Lichro

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He, Guodong, Liping Mai, and Xipei Wang. "Development and Validation of an HPLC-MS/MS Method for Rapid Simultaneous Determination of Cefprozil Diastereomers in Human Plasma." International Journal of Analytical Chemistry 2018 (September 13, 2018): 1–9. http://dx.doi.org/10.1155/2018/6959761.

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Background. Both cis- and trans-cefprozil have antimicrobial activity, but their potencies are quite different. It is therefore necessary to develop a sensitive method to simultaneously determine both isomers for pharmacokinetic and bioequivalence studies. Methods. An LC-MS/MS method, using stable isotope-labeled cefprozil as the internal standard, was developed and validated. The analytes were extracted from plasma by protein precipitation and separated on a reverse-phase C18 column using a gradient program consisting of 0.5% formic acid and acetonitrile within 4 min. The mass spectrometry ac

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Das, S., D. Halder, S. Dan, E. Biswas, C. Saha, and T. K. Pal. "METHOD DEVELOPMENT, VALIDATION AND PLASMA ANALYSIS OF ETORICOXIB USING LC-MS/MS IN INDIAN HEALTHY HUMAN VOLUNTEERS." INDIAN DRUGS 56, no. 11 (2019): 34–41. http://dx.doi.org/10.53879/id.56.11.11764.

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A rapid, highly sensitive, accurate and cost effective simple high performance liquid chromatographic tandem mass spectrometry (LC-MS/MS) method was developed and validated for the evaluation of cyclooxygenase-2 inhibitor etoricoxib in human plasma after administration of a single oral dose 60 mg tablet, using metoprolol as internal standard (IS). etoricoxib and metoprolol (Internal Standard) were extracted from the human plasma by protein precipitation extraction technique (PPT) by using cold acetonitrile, and separated by C18 analytical column (50 x 3 mm, particle Size- 5 μm). Both etoricoxi

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Fresnais, Margaux, André Roth, Kathrin I. Foerster, et al. "Rapid and Sensitive Quantification of Osimertinib in Human Plasma Using a Fully Validated MALDI–IM–MS/MS Assay." Cancers 12, no. 7 (2020): 1897. http://dx.doi.org/10.3390/cancers12071897.

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The third-generation tyrosine kinase inhibitor (TKI), osimertinib, has revolutionized the treatment of patients with non-small cell lung carcinoma with epidermal growth factor receptor (EGFR)-activating mutation, and resistant to first- and second-generation TKIs. Osimertinib is now also proposed as a first-line therapy, thus extending the scope of applications in lung oncology. Personalized medicine approaches are still necessary to monitor if patients are exposed to adequate concentrations of osimertinib during their treatment. It would also help to understand the appearance of new resistanc

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Ogawa-Morita, Tomoko, Yoshiyuki Sano, Tomoka Okano, et al. "Validation of a Liquid Chromatography-Tandem Mass Spectrometric Assay for Quantitative Analysis of Lenvatinib in Human Plasma." International Journal of Analytical Chemistry 2017 (2017): 1–6. http://dx.doi.org/10.1155/2017/2341876.

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Toward conducting clinical pharmacokinetic studies of an antineoplastic agent, lenvatinib, we developed a liquid chromatography-tandem mass spectrometric assay for its quantitative analysis in human plasma. Analyte (lenvatinib) and internal standard (IS, propranolol) in the plasma were extracted by using acetonitrile and chromatographically separated by using a XTerra MS C18 column with 0.2 mL/min flow and mobile phase starting with 0.1% formic acid in water, followed by increasing percentage of acetonitrile. Detection was performed by using combined reversed-phase liquid chromatography-tandem

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Favreto, Wagner Alex Jann, Ana Maria Pugens Pinto, Josélia Larger Manfio, Ivonete Hoss, Mariely Camila Pristch, and Solange Fátima Bordignon. "Development and Validation of an Ultra-Performance Liquid Chromatography/Electrospray Ionization-Tandem Mass Spectrometry Bioanalytical Method for Quantifying Clonazepam in Human Plasma." Journal of AOAC INTERNATIONAL 96, no. 4 (2013): 745–50. http://dx.doi.org/10.5740/jaoacint.11-263.

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Abstract A sensitive, selective, and rapid ultra-performance LC (UPLC)/MS/MS method was validated for the confirmation and quantification of clonazepam in human plasma. The analyte was extracted from human plasma with diethyl ether, reaching an average recovery of 64.02 and 66.48% for clonazepam and the internal standard, respectively. The separation was performed on a Waters ACQUITY UPLC™ BEH C18 column (50 × 2.1 mm id, 1.7 μm particle size) with gradient elution at a flow rate of 0.25 mL/min using a 0.5% formic acid solution (mobile phase A) and acetonitrile–methanol–formic acid (75 + 25 + 0

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Dayyih, Wael Abu, Mohammed Hamad, Ahmad Abu Awwad, et al. "A Liquid Chromatography-Tandem Mass Spectrometry Method for Evaluation of Two Brands of Enalapril 20 mg Tablets in Healthy Human Volunteers." Journal of Analytical Methods in Chemistry 2017 (2017): 1–8. http://dx.doi.org/10.1155/2017/8489471.

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Enalapril is an angiotensin-converting enzyme inhibitor used for treatment of hypertension and chronic heart disease. Enalaprilat is its active metabolite responsible for the activity. This study aimed to develop and validate a method for enalapril and enalaprilat analysis and to determine the bioequivalence of two tablet formulae of enalapril. LC-MS/MS bioanalytical method was developed and validated and then applied to evaluate the bioavailability of two enalapril formulae. Antihyperglycemic sitagliptin was used as internal standard (IS). The method was accurate for the within- and between-d

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Challa, Balasekhara R., Sai H. S. Boddu, Bahlul Z. Awen, et al. "Development and validation of a Sensitive bioanalytical method for the quantitative estimation of Pantoprazole in human plasma samples by LC–MS/MS: Application to bioequivalence study." Journal of Chromatography B 878, no. 19 (2010): 1499–505. http://dx.doi.org/10.1016/j.jchromb.2010.03.049.

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Manfio, Josélia Larger, Mauricio Bedim dos Santos, Wagner Alex Jann Favreto, Fabiane Ines Hoffmann, and Adriana Cristina Mertin. "Validation of a Liquid Chromatographic/Tandem Mass Spectrometric Method for the Determination of Scopolamine Butylbromide in Human Plasma: Application of the Method to a Bioequivalence Study." Journal of AOAC INTERNATIONAL 92, no. 5 (2009): 1366–72. http://dx.doi.org/10.1093/jaoac/92.5.1366.

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Abstract A sensitive and specific LC/MS/MS method was developed and validated for the determination of scopolamine butylbromide in human plasma. Scopolamine butylbromide and propanolol (internal standard) were extracted from the plasma by liquidliquid extraction with dichloromethane as the extraction solvent and separated on a C18 analytical column (50 4.6 mm id) maintained at 40C. The analytes were eluted at a constant flow rate of 0.45 mL/min; the mobile phase consisted of acetonitrile and a buffer of 5 mM ammonium acetate and 0.1 formic acid (60 + 40, v/v). The mass spectrometer, equipped w

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Phaneendra Rao, P. G., and Battula Sreenivasa Rao. "Development and Validation of Novel Analytical LC-MS Method for Simultaneous Quantification of Calcitonin Gene-Related Peptide Receptor Antagonists Ubrogepant and Atogepant in Human Plasma." Asian Journal of Chemistry 34, no. 11 (2022): 2865–71. http://dx.doi.org/10.14233/ajchem.2022.23913.

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A simple, highly sensitive and selective liquid chromatography/tandem mass spectrometry (LC-MS/MS) method was developed and validated for separation and simultaneous assay of approved calcitonin gene-related peptide receptor antagonists ubrogepant and atogepant in human plasma using frovatriptan as internal standards. Analytes were extracted using protein precipitation induced by acetonitrile followed by liquid-liquid extraction using dichloromethane. RP-HPLC analysis was carried using Xbridge C18 column (50 mm × 4.6 mm, 5 μm) with a simple isocratic mobile phase composed of 0.01% NH3 in 2 mM

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Fischle, Alica, Rico Schwarz, Franziska Wendt, et al. "A Sensitive LC-MS/MS Method for the Simultaneous Determination of Two Thia-Analogous Indirubin N-Glycosides and Indirubin-3′-Monoxime in Plasma and Cell Culture Medium." Molecules 27, no. 9 (2022): 3031. http://dx.doi.org/10.3390/molecules27093031.

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Indirubin was identified as an active component of Danggui Longhui Wan, an herbal mixture used in traditional Chinese medicine, and showed anticancer activity in clinical trials in patients with chronic leukemia. Investigations on the mechanisms of antitumor action of indirubins have mainly focused on the indirubin derivative indirubin-3′-monoxime (I3M). Meanwhile, antiproliferative and cytotoxic properties on cancer cells have also been demonstrated for several synthetic indirubin N-glycosides. In the present study, we demonstrate cytotoxic activity of the thia-analogous indirubin N-glycoside

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Nguyen, Duc Tuan, Trung Nguyen Nguyen Le, Duc Kien Ngo, et al. "Development and Validation of an HPLC-MS/MS Method for the Simultaneous Quantification of Vitexin and Isovitexin in Rabbit Plasma: Pharmacokinetic Insights on a Microcapsule Formulation." Molecules 30, no. 8 (2025): 1690. https://doi.org/10.3390/molecules30081690.

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Vitexin and isovitexin are natural flavone C-glucosides that have numerous benefits for human health. However, their low oral bioavailability and poor gastrointestinal absorption dramatically restrict their potential medicinal uses. To overcome this challenge, chitosan-coated alginate microcapsules were prepared for intragastrical administration to rabbits. An LC-MS/MS method was developed and validated for the simultaneous determination of vitexin and isovitexin in the plasma of treated rabbits, using salicylic acid as the internal standard. Raw rabbit plasma samples were deproteinized using

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Viswanathan, Sekarbabu, Priya Ranjan Prasad Verma, and Muniyandithevar Ganesan. "A Validation and Estimation of Total Eicosapentaenoic and Docosahexaenoic acids Using LC-MS/MS with Rapid Hydrolysis Enzymatic Method for Hydrolysis of Omega Lipids in Human Plasma and its Application in the Pharmacokinetic Study." Current Pharmaceutical Analysis 15, no. 2 (2019): 172–93. http://dx.doi.org/10.2174/1573412914666180730094803.

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Background: In this study, we have developed a novel, rapid enzymatic hydrolysis method for conversion of omega lipids (omega fatty acid triglycerides, phospholipids, omega conjugates) in to free fatty acids at room temperature using lipase and esterase enzymes. </P><P> Objective: To develop simple enzymatic hydrolysis and rapid sample extraction method for quantification of free (un-esterified) and conjugated (esterified) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) to provide the total EPA and DHA lipids present in human plasma. Quantification of total EPA/DHA was p

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Kumar, Ashok, Dr D. B. Joshi, and Dr R. S. Bhadauria. "“BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF PROPOFOL IN K3EDTA HUMAN PLASMA BY USING LC-ESI-MS/MS”." Journal of Biomedical and Pharmaceutical Research 8, no. 5 (2019). http://dx.doi.org/10.32553/jbpr.v8i5.659.

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Bioanalytical method development is the process of creating a procedure to enable a compound of interest to be identified and quantified in a biological matrix. A compound can often be measured by several methods and the choice of analytical method involves many considerations. Analysis of drugs and their metabolites in a biological matrix is carried out using different extraction techniques like liquid-liquid extraction, solid phase extraction (SPE) and protein precipitation from these extraction methods samples are spiked with calibration (reference) standards and using quality control (QC)

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Nagaraju, K., Y. A. Chowdary, and M. V. Basaveswara Rao. "Development and validation of bexarote by bioanalytical methods using liquid chromatography-tandem mass spectroscopy (LC-MS/MS)." Future Journal of Pharmaceutical Sciences 7, no. 1 (2021). http://dx.doi.org/10.1186/s43094-020-00155-6.

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Abstract Background The aim of this study was to develop and validate accurate and precise UPLC method with tandem mass spectrometry (Waters) for the determination of bexarotene in human plasma using bexarotene D4 as internal standard (IS). Results The retention time of bexarotene was 2.75 ± 0.30 min. The method was validated with respect to system suitability, linearity, accuracy, precision, matrix effect, auto sampler carryover test, and recovery. Linearity was found to be 1.04 to 351.93 μg/mL. LOQQC, LQC, INTQC, MQC, and HQC were found to be 1.0550, 2.7800, 25.2700, 131.61, and 263.23 respe

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-, Mayur S. Ingle, Shraddha K. Khatri -, Dr Balaji N. Thakare -, and Dr Kailash Biyani -. "An Overview of the Development and Validation of Bioanalytical Methods and Their Use in Pharmacy." International Journal on Science and Technology 16, no. 2 (2025). https://doi.org/10.71097/ijsat.v16.i2.3683.

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According to this review article, bioanalytical techniques are frequently employed to measure medications and their metabolites in plasma matrices, and these techniques ought to be used in both nonhuman and human clinical research. Drugs and their metabolites are quantitatively estimated using a bioanalytical approach in biological media, which is crucial for estimating and interpreting pharmacokinetic, toxicokinetic, and bioequivalence data research. Sample analysis, method development, and method validation are the main bioanalytical functions. To determine the degree to which environmental,

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HALDER, DHIMAN, SOURAV DAS, BALARAM GHOSH, et al. "AN LC-MS/MS BASED BIOANALYTICAL APPROACH TO RESOLVE PHARMACOKINETIC INVESTIGATION OF ACOTIAMIDE HYDROCHLORIDE AND ITS APPLICATION TO BIOEQUIVALENCE STUDY." International Journal of Pharmacy and Pharmaceutical Sciences, September 2, 2020, 76–84. http://dx.doi.org/10.22159/ijpps.2020v12i10.38410.

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Objective: Acotiamide, a prokinetic drug used to treat Functional Dyspepsia, which acts by modulating gastric motility. However, in this present study, a simple and accurate bioanalytical method was developed for the estimation of Acotiamide in human plasma using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and validated according to US-FDA guideline. Methods: The method was developed in blank human blood plasma; propranolol was used as internal standard (IS). Protein Precipitation technique was followed for the extraction of the drug from the plasma sample. In liquid chroma

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Bezawada, Viritha, Padma Mogili, Sireesha Dodda, and Ramakrishna Gajula. "Bioanalytical method for estimation of procyclidine in human plasma using liquid chromatography-tandem mass spectrometry: Application to pharmacokinetic study." European Journal of Mass Spectrometry, July 3, 2022, 146906672211111. http://dx.doi.org/10.1177/14690667221111153.

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A rapid, selective and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for quantification of procyclidine hydrochloride in human plasma using Procyclidine D11 hydrochloride as internal standard. Liquid-liquid extraction technique with methyl tertiary butyl ether was used for the extraction of plasma samples. Chromatographic separation of the analyte and the internal standard from the endogenous components was done on Zodiac C18 column (50 × 4.6 mm, 5 µm) using a mixture of methanol and 0.1% formic acid in water (70:30, v/v) as mobile phase

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Filonova, U. D., P. K. Karnakova, K. K. Karnakova, et al. "Development and Validation of an HPLC-MS/MS Method for Quantification of Apixaban in Human Plasma." Drug development & registration, February 20, 2024. http://dx.doi.org/10.33380/2305-2066-2024-13-1-1684.

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Introduction. Apixaban is an anticoagulant used in a number of thromboembolic diseases with an improved benefit-to-risk ratio, according to multiple clinical studies. Due to the prescription of apixaban as antithrombotic therapy in patients with COVID-19, an increase in its use has been observed. Thus, due to the widespread use of apixaban and the need to conduct pharmacokinetic and bioequivalence studies of the drug, it is important to develop and validate a simple and sensitive method for the quantitative determination of apixaban in human blood plasma.Aim. The aim of the study is to develop

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Deshpande, Mahesh M., Madhuri H. Bhalerao, and Pooja D. Pabale. "A Review on Impurity Profiling, Degradation Studies, and Bioanalytical Methods of Anti-diabetic Drugs." Journal of Pharmaceutical Research International, April 26, 2022, 43–71. http://dx.doi.org/10.9734/jpri/2022/v34i34b36156.

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According to ICH Q3A(R), the impurity in a new drug substance is “any component of a new drug substance that is not the chemical entity defined as a new drug substance”. As Per ICH Q3B(R), the impurity in a new drug product is “any component of the drug product that is not the drug substance and excipients in the drug product. “The forced degradation studies are used to facilitate the development of analytical methodology, to achieve a better understanding of the drug substance and the drug product stability, and to determine degradation pathways and the degradation products. This study will h

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Ganta, Kiran Kumar, and Raja Sundararajan. "LC-MS Approach for Comprehensive Monophosphoramidite Prodrug Monitoring in Human Plasma." INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE, December 25, 2024. https://doi.org/10.25258/ijpqa.15.4.23.

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Current research initiatives constitute a multifaceted approach to address the complexities of the pandemic, involving the study of an antiviral drug known as Mono Phosphoramidite pro drug, pharmacological investigations, and advanced diagnostics. Analytical methods for detecting and quantifying antiviral compounds have also evolved over the past decade, with relevance to COVID-19 treatment. This research critically assesses sample pre-treatment and extraction methods, detection and quantification techniques, and methods with preliminary separation steps. The major goal of this study is to con

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Chen, Hui, Junping Guo, Zhenyu Zhu, Xiaomei Huang, and Jincai Guo. "A sex-sensitive LC-MS/MS method with isotopic internal standard for prazosin bioequivalence: bridging precision medicine and generic drug policy in China." Frontiers in Pharmacology 16 (May 23, 2025). https://doi.org/10.3389/fphar.2025.1592731.

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ObjectiveTo develop a rapid, sensitive, and high-throughput liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for prazosin quantification in human plasma, validate its application in bioequivalence studies, and investigate sex-specific pharmacokinetic differences in a Chinese population.Materials and methodsPlasma samples were processed by protein precipitation with methanol and analyzed using a Waters ACQUITY UPLC® HSS T3 column. Prazosin-d8 was used as an isotopic internal standard (IS) to enhance quantification accuracy. Chromatographic separation was performed with methanol

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VATSAVAYI, JAGAPATHI RAJU, and NALANDA BABY REVU. "METHOD DEVELOPMENT AND VALIDATION OF A HIGHLY SELECTIVE AND SPECIFIC POSITIVE POLARITY ESI-LC-MS/MS METHOD FOR SIMULTANEOUS DETERMINATION OF SEMAGLUTIDE AND CANAGLIFLOZIN IN HUMAN PLASMA." International Journal of Applied Pharmaceutics, May 7, 2025, 312–21. https://doi.org/10.22159/ijap.2025v17i3.53379.

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Objective: To develop a method capable of simultaneous estimation and quantification of semaglutide and canagliflozin being studied as a potential combination therapy for treating Diabetes. Materials: An elaborate protein precipitation extraction technique used verapamil as internal standards for semaglutide and canagliflozin. The two compounds were separated on a Zorbax C18 (50 mm x 2.1 mm, 5 µ Particle size) column, with a positive polarity Electro Spray Ionization (ESI) on a Liquid chromatograph with Tandem Mass Spectrometry (LC-MS/MS) instrument. The estimation was through a Multiple React

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VATSAVAYI, JAGAPATHI RAJU, and NALANDA BABY REVU. "DEVELOPMENT AND VALIDATION OF A SPECIFIC AND UNIQUE DUAL POLARITY ESI-LC-MS/MS METHOD FOR SIMULTANEOUS DETERMINATION OF SEMAGLUTIDE AND DAPAGLIFLOZIN IN HUMAN PLASMA." International Journal of Applied Pharmaceutics, September 7, 2024, 350–58. http://dx.doi.org/10.22159/ijap.2024v16i5.51095.

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Objective: To develop a method capable of simultaneous quantification and estimation of semaglutide and dapagliflozin which are being studied as a prospective combination therapy for treating Diabetes. Methods: An intricate protein precipitation extraction technique was employed using verapamil and tolbutamide as internal standards for semaglutide and dapagliflozin, respectively. The two compounds were separated on a Kinetex C18 (50 mm x 2.1 mm, 5 µ Particle size) column, with a dual polarity ionization Electro Spray Ionization (ESI) on a Liquid chromatograph Tandem Mass Spectrometry (LC-MS/MS

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