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

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

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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2

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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3

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 &amp; 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 &amp; 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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5

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 &gt; &gt; 148 for fluoxetine and m/z [M + H]+ 315.1 &gt; &gt; 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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