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Journal articles on the topic 'Tacrolimus Validation ICH Guidelines'

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Published: 4 June 2025

Last updated: 1 August 2025

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1

Camargo, Guilherme A., Amanda M. Lyra, Fernanda M. Barboza та ін. "Validation of Analytical Methods for Tacrolimus Determination in Poly(ε-caprolactone) Nanocapsules and Identification of Drug Degradation Products". Journal of Nanoscience and Nanotechnology 21, № 12 (2021): 5920–28. http://dx.doi.org/10.1166/jnn.2021.19500.

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The aim of this paper was to use chromatographic tools for validating an analytical method for the tacrolimus (TAC) determination in polymeric nanocapsules and for identifying the drug degradation products after alkaline stress. A rapid Ultra-High-Performance Liquid Chromatography coupled with photo-diode array (UHPLC-PDA) method was successfully performed using the following chromatographic conditions: the Shimadzu Shim-pack XR-ODS III C18 column (100 mm×2.00 mm, 2.2 μm), the mobile phase consisting of methanol and acidified ultrapure water (89:11 v/v), the flow rate of 0.55 mL·min−1, and the

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Bhatia, Ritika, Rakesh Goyal, and Dilip Agarwal. "Process Validation of Paracetamol tablet as per ICH guidelines." International Journal of Medical and Biomedical Studies 7, no. 6 (2023): 11–23. http://dx.doi.org/10.32553/ijmbs.v7i6.2713.

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Process validation is an integral part of pharmaceutical manufacturing, ensuring that tablets are consistently produced with quality and efficacy in line with regulatory requirements. The International Council for Harmonization ICH) provides guidelines for the systematic validation of manufacturing processes. This research article presents a comprehensive study on process validation for Paracetamol tablets following the ICH guidelines. The article focuses on various aspects of the validation process, including process design, qualification, and continued process verification, with specific emp

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Elumalai, Selvaraja, Venkata Lakshamana Sagar Dantinapalli, and Mylsamy Palanisamy. "Comparative Analysis of Analytical Method Validation Requirements Across ICH, USP, ChP and ANVISA: A Review." Journal of Pharmaceutical Research International 36, no. 12 (2024): 54–71. http://dx.doi.org/10.9734/jpri/2024/v36i127628.

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This comprehensive guide provides a detailed comparison of analytical method validation requirements across four major regulatory bodies: the International Council for Harmonisation (ICH), United States Pharmacopeia (USP), Chinese Pharmacopoeia (ChP), and Brazilian Health Regulatory Agency (ANVISA). The study examines key aspects of method validation, including scope, validation parameters, acceptance criteria, and regulatory compliance. These guidelines have been chosen due to major differences between regulations requirements and ICH guidelines, leading to a huge challenge for the Health Aut

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Bhatia, Ritika, Mo Firoj Tanwar, Rakesh Goyal, and Dilip Agarwal. "Process Validation of Paracetamol Tablets: A Comprehensive Study Based on ICH Guidelines." International Journal of Medical and Biomedical Studies 7, no. 6 (2023): 01–10. http://dx.doi.org/10.32553/ijmbs.v7i6.2712.

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This research paper aims to provide a comprehensive understanding of the process validation of Paracetamol tablets according to the guidelines outlined by the International Council for Harmonisation of Technical Requirements forPharmaceuticals for Human Use (ICH). Paracetamol is a widely used analgesic and antipyretic drug, and ensuring the quality, safety, and efficacy of its dosage form is of utmost importance. This study encompasses the three stages of process validation, namely process design, process qualification, and continued process verification, with a focus oncritical parameters and

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Sahu, Sandeep, and Narendra Kumar Lariya. "Development and Validation of Spectrophotometric Method for the Estimation of Enoxaparin sodium in marketed formulation." Journal of Drug Delivery and Therapeutics 9, no. 4-s (2019): 1236–39. http://dx.doi.org/10.22270/jddt.v9i4-s.3972.

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Simple, cost effective, precise and accurate UV-Spectrophotometric method for estimation of Enoxaparin sodium was developed and validated as per ICH guidelines. This Method involves solving of calibration curve based on measurement of absorbance wavelengths 234nm in 0.1 N HCl. The method obeys the Beer’s law in the concentration ranges 100-500µg/ml. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. % Recovery for both the drugs were in the range of 99.28

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JAGIRAPU, BANGARUTHALLI, U. Harini, M. Divya, and P. Sushma. "Simultaneous estimation of telmisartan and atorvastatin calcium in API and tablet dosage form." Journal of Drug Delivery and Therapeutics 9, no. 1 (2019): 175–79. http://dx.doi.org/10.22270/jddt.v9i1.2268.

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A new method has been established for the simultaneous estimation of Telmisartan and Atorvastatin calcium by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Telmisartan and Atorvastatin calcium by using boston ODS C18 column, flow rate was 1.0ml/min, mobile Phase consists of methanol:Acetonitrile:buffer in ratio of 35:25:40. Detection wave length was 235nm.The instrument used was SHIMADZU HPLC auto sampler. The retention time of Atorvastatin calcium and Telmisartan was found to be 2.350 and 3.490 minutes respectively. The analytical method was v

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Mandhare, Shubham, Rahul Godge, Akshay Vikhe, and Shubham Talole. "Development and validation of a QbD-based RP-HPLC method for vericiguat quantification." Journal of Applied Pharmaceutical Research 12, no. 2 (2024): 57–67. http://dx.doi.org/10.18231/j.joapr.2024.12.2.57.67.

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Aim: An RP-HPLC method for Vericiguat using the QbD approach was developed and validated by ICH guidelines. Method: The ICH (Q2R1) guidelines have been followed in the development and validation of an RP-HPLC technique by considering several validation parameters like linearity, precision, LOD, LOQ, and accuracy. The study was performed on Agilent Tech using the C18 column (4.6x250 mm; 5 µm) and Chemstation 10.1 software with statistical data analysis, and the detector used was UV (DAD). Results: The mobile phase used for separation was Methanol: 0.1% OPA in the ratio of (76:24) at room temper

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Ahirwar, Sonu, Varsha Kashaw, Ravish Sahu, Surbhi Chourasia, Vaibhav Rajoria, and Prakash Kushwaha. "UV Spectrophotometric Method Development and Validation of Butorphanol Tartrate in Bulk Drug and Pharmaceutical Formulation." Journal of Drug Delivery and Therapeutics 14, no. 4 (2024): 77–80. http://dx.doi.org/10.22270/jddt.v14i4.6521.

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The present research work discusses the development and validation of a UV spectrophotometric method for butorphanol tartrate. Simple, accurate and cost efficient spectrophotometric method has been developed for the estimation of butorphanol tartrate in tablet dosage form. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λ max) was found to be 278nm. The percentage recovery of butorphanol tartrate was in the 100.016±0.68. Beers law was obeyed in the concentration range of 2-12μg/ml. Calibration curves shows a linear relationship between the absorban

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Chawale, Prajakta A., Dinesh R. Chaple, Alpana J. Asnani, and Kumar Pratyush. "Development and Validation of UV Spectrophotometric Method for Estimation Ibandronate sodium in Pharmaceutical Formulation." Journal of Drug Delivery and Therapeutics 9, no. 3 (2019): 339–43. http://dx.doi.org/10.22270/jddt.v9i3.2675.

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A simple, accurate, precise, rapid spectrophotometric method for estimation of Ibandronate sodium in pharmaceutical formulation. Ibandronate sodium is one off the nitrogen carrying bisphosphonate. It prevents osteoclast-conciliate bone resorption, Paget’s disease, postmenopausal osteoporosis. The maximum wavelength (λmax) of ibandronate sodium is 218nm. Linearity was observed in the concentration range 2-100µg/ml. The coefficient of variation value was found to be 0.3499. Amount of drug estimated from tablet formulation were in precise with label claim. The method was statistically validated a

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Shantappa Birajdar, Arunadevi. "New Method Development by HPLC and Validation as per ICH Guidelines." Acta Scientific Pharmaceutical Sciences 4, no. 4 (2020): 55–60. http://dx.doi.org/10.31080/asps.2020.04.0517.

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Akram, N. Md, and M. Umamahesh. "ICH Guidelines on Method Development and Validation by RP-HPLC Method." Journal of Chemistry and Chemical Sciences 7, no. 12 (2017): 1179–82. http://dx.doi.org/10.29055/jccs/526.

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Prajapati, J. B., H. Rao, and H. Shah. "DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF SELEGILINE HYDROCHLORIDE LOADED SOLID LIPID NANOPARTICLES." INDIAN DRUGS 56, no. 08 (2019): 57–60. http://dx.doi.org/10.53879/id.56.08.11297.

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The present paper discusses about a simple, precise and validated method for the determination of selegiline loaded solid lipid nanoparticles. The study was carried as per the parameters laid down in ICH guidelines. Maximum wavelength of selegiline in 8:2 methanol: chloroform mixture was selected at 258nm. The method was found to be linear in the range of 200μg/mL to 1000μg/mL with correlation coefficient R2 of 0.994. Method was successfully validating as per ICH guidelines. Moreover, this method was simple, sensitive and easy to apply and can be performed at laboratory scale. Hence, the propo

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Shareef, Isteyaq, and Kumaraswamy Gandla. "Stability-Indicating UPLC Method Development and Validation for Sulfamethoxazole and Trimethoprim Injection with Comprehensive Forced Degradation Profiling." Journal of Drug Delivery and Therapeutics 15, no. 6 (2025): 132–36. https://doi.org/10.22270/jddt.v15i6.7224.

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Objective: To develop and validate a stability-indicating UPLC method for the simultaneous estimation of Sulfamethoxazole and Trimethoprim in injectable dosage form, including comprehensive forced degradation profiling as per ICH guidelines. Design: Experimental study involving method development, validation, and forced degradation in accordance with ICH Q2(R1) and Q1A(R2) protocols. Intervention: Chromatographic separation was achieved using a C18 column (150×4.6 mm, 5 µm) with a mobile phase of Methanol:Acetonitrile (80:20 v/v), a flow rate of 1.0 mL/min, and UV detection at 254 nm. Main Out

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S. Harshini and T. Sudha. "QbD- QUALITY BY DESIGN ANALYTICAL METHOD DEVELOPMENT AND VALIDATION-AN OVERVIEW." RASAYAN Journal of Chemistry 17, no. 03 (2024): 1309–14. http://dx.doi.org/10.31788/rjc.2024.1738778.

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The idea of "Quality by Design" (QbD) has attracted much focus among the prescription drugs sectors for sustaining Quality. It acts as a link between the pharmaceutical sector and drug regulating agencies, supporting the shift to a proactive, scientific, risk-based, and integrated method for approaching pharmaceutical product creation. It mostly entails creating formulas and manufacturing procedures to ensure product quality. The design, development, and production of high-quality pharmaceutical goods are areas where QbD can add value. FDA, the Food and Drug Administration & the Internatio

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Borkar, Dinesh P., Anup Barsagade, Nobel CP James, Suruchi Thakare, and Susmita Mandal. "Analytical Method Developement and Validation of Beclomethasone, Clotrimazole, Ofloxacin, Lidocaine by RP-HPLC in Combination Dosage Form." Journal of Pharmaceutical Research International 36, no. 11 (2024): 163–73. http://dx.doi.org/10.9734/jpri/2024/v36i117609.

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A rapid and precise method (in accordance with ICH guidelines) is required for the quantitative simultaneous determination of drugs in a combined pharmaceutical dosage form. The pursuit of desired quality is a continual challenge for pharmaceutical industries, necessitating a meticulous approach known as validation. Sensitive and specific RP-HPLC method involving UV detection was carried for determination and quantification of various drug in combination dosage form. The aim is "Analytical Method developement and Validation of Beclomethasone, Clotrimazole, Ofloxacin, Lidocaine by RP- HPLC In C

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Mohammad, Afrin Roshanara* Mekala Indu Bhavani A. Elphine Prabahar and Rama Rao Nadendla. "DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR ANALYSIS OF ENALAPRIL MALEATE IN BULK AND PHARMACEUTICAL DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 02 (2019): 4049–53. https://doi.org/10.5281/zenodo.2567493.

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<em>A simple, accurate, sensitive, precise and economical spectroscopic method has been developed and validated for the determination of enalapril maleate in bulk and tablet dosage form. The solvent used is double distilled water for solubilizing purpose. The drug shows the absorption maxima of 211nm. The method obeys Beer’s law in the concentration range of 10-60  μg/mL and exhibited good correlation coefficient (R2=0.9983). The developed method is validated statistically as per ICH guidelines for linearity, precision and accuracy.</em> <strong>Keywords: </strong><em>Enalapril m

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Kulkarni, Dipak Chandrakant, Anima Sunil Dadhich, and Mukthinuthalapati Mathrusri Annapurna. "Analytical method development and validation for the evaluation of related substances in Apalutamide by RP-HPLC." Journal of Drug Delivery and Therapeutics 14, no. 6 (2024): 150–60. http://dx.doi.org/10.22270/jddt.v14i6.6641.

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Apalutamide is an anti-cancer agent used for the management of prostate cancer. A new stability indicating RP-HPLC method (Gradient mode) has been developed for the estimation of Apalutamide and its related substances using Waters Alliance system (Model no. 2996 and 2695) with Inertsil ODS-3 (250 × 4.6 mm, 5μm) column (PDA detector) was used for the present study. A mixture of Ammonium phosphate buffer solution and Acetonitrile (30: 70, v/v) was used as the mobile phase for the chromatographic study (Flow rate: 1.0 mL/min; Detection wavelength: 243 nm). Stress degradation studies were performe

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Anjani, Qonita Kurnia, Akmal Hidayat Bin Sabri, and Ryan F. Donnelly. "Development and validation of simple and sensitive HPLC-UV method for ethambutol hydrochloride detection following transdermal application." Analytical Methods 14, no. 2 (2022): 125–34. http://dx.doi.org/10.1039/d1ay01414e.

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Shrivastava, Suman, Pooja Deshpande, and S. J. Daharwal. "Key Aspects of Analytical Method Development and Validation." Journal of Ravishankar University (PART-B) 31, no. 1 (2019): 32–39. http://dx.doi.org/10.52228/jrub.2018-31-1-6.

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Development of a method is crucial for discovery, development, and analysis of medicines in the pharmaceutical formulation. Method validation could also be thought to be one in all the foremost well-known areas in analytical chemistry as is reproduced within the substantial variety of articles submitted and presented in peer review journals every year. Validation of an analytical procedure is to demonstrate that it's appropriate for its intended purpose. Results from method validation are often wont to decide the quality, reliability and consistency of analytical results. Analytical methods ne

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Biswal, Sabyasachi, and Sumanta Mondal. "Analytical Method Validation Report for Assay of Lapatinib by UPLC." Pharmaceutical Methods 10, no. 1 (2019): 6. https://doi.org/10.5281/zenodo.14586180.

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Objective: A new, simple, rugged, rapid, robust and precise ultra-performance liquid chromatographic (UPLC) method for estimation of Lapatinib in a bulk and tablet dosage form has been developed and validated according to ICH Guidelines. Methods: The chromatographic separation was achieved using BHEL UPLC Column. The mobile phase used was a mixture of 0.1% OPA buffer 300 ml (30%) and 700ml Acetonitrile (70%) at isocratic mode and eluents were monitored at 309 nm using PDA detector. Results: By the method Lapatinib was eluted with retention time of 0.516 mins. The method was continued and valid

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Singh, Anamika, and Tamanna Narsinghan. "BIOANALYTICAL METHOD VALIDATION: A COMPREHENSIVE ASSESSMENT OF VARIOUS REGULATORY GUIDELINES." Indian Drugs 60, no. 06 (2023): 7–25. http://dx.doi.org/10.53879/id.60.06.12583.

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Bioanalytical methods are used to analyse an analyte in a biological matrix. Bioanalytical method validation is the process of determining the suitability of the given bioanalytical methodology for providing the required analytical data. Validation of the bioanalytical methods demonstrates and ensures that the methods used for the quantification of analyte in biological fluids are reliable, reproducible and suitable for its intended application. Different regulatory agencies like Food and Drug administration (FDA), The National Health Surveillance Agency or Agência Nacional de Vigilância Sanit

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Shah, Devanshi, Vinit Movaliya, Shruti Kharidia, and Maitreyi Zaveri. "Comparative Study of Analytical Method Validation and Process Validation parameters as per ICH, EMA, WHO and ASEAN guidelines." International Journal of Drug Regulatory Affairs 12, no. 2 (2024): 58–64. http://dx.doi.org/10.22270/ijdra.v12i2.675.

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Objective: Compare and analyse analytical method validation and process validation requirements across ICH, EMA, WHO, and ASEAN guidelines, alongside relevant literature. Summary: In the pharmaceutical industry, ensuring the quality, safety, and effectiveness of medicinal products is of utmost importance. Analytical Method Validation (AMV) and Process Validation (PV) are critical procedures in pharmaceutical manufacturing, vital for upholding product quality and adhering to regulatory standards. This thesis undertakes a comparative examination of AMV and PV guidelines from prominent regulatory

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Kartik, A. Bhatkar*1 V. M. Waghulkar2 M. P. Jadhao3 M. D. Game4 S. G. Jawarkar5. "Analytical Method Development And Validation For Simultaneous Estimation Of Antidibetic Drugs In Bulk And Marketed Formulation." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 524–31. https://doi.org/10.5281/zenodo.11183408.

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A new, simple, selective, accurate, rapid and precise   High-Performance Liquid Chromatographic technique of Dapagliflozin and Linagliptin was established as per ICH Guidelines. HPLC was performed on a Hypersil BDS Column C18, 5 µm particle size, 245 cm × 4.6 mm with phosphate buffer and acetonitrile, Methanol in the ratio of 15: 15: 70 v/v as a mobile phase and a flow rate of 1.0 ml min-1. UV detection was performed at 284 nm.  The retention time of Dapagliflozin was found to be 3.961 minutes, and Linagliptin was found to be 3.451.  Validation of the developed

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Gniazdowska, Elżbieta, Edyta Gilant, and Katarzyna Buś-Kwaśnik. "ICH M10 guideline - a harmonized global approach to bioanalysis." Prospects in Pharmaceutical Sciences 21, no. 3 (2023): 57–63. http://dx.doi.org/10.56782/pps.152.

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Bioanalytical methods are used in research on small-molecule and large-molecule drug products to determine analytes and their metabolites in biological matrices such as blood, plasma, serum, urine, feces, saliva, other biological fluids, or tissues. Validation of a bioanalytical method is the essential step before the implementation of the method into routine use in toxicokinetic or pharmacokinetic studies. Harmonization of recommendations for the validation of bioanalytical methods has been advocated for many years. In 2022, The International Council for Harmonisation of Technical Requirement

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Shivaraj, Anusha, and Shireesha Battula. "Method Development and Validation of RP-HPLC Method for the Estimation of Ormeloxifene." INTERNATIONAL JOURNAL OF APPLIED PHARMACEUTICAL SCIENCES AND RESEARCH 2, no. 03 (2017): 78–82. http://dx.doi.org/10.21477/ijapsr.v2i03.8253.

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A new simple, specific, accurate, precise RP-HPLC method has been developed for the estimation of Ormeloxifene. The chromatographic separation for Ormeloxifene was achieved with mobile phase containing methanol :ACN(70:30 v/v), agilent C18 column (4.6 x150 mm) 5 μ at room temperature and UV detection at 274nm.The compounds were eluted in the isocratic mode at a flow rate of 1ml/min. The retention time of Ormeloxifene was found to be 2.497min. The method was validated according to ICH guideline for linearity, specificity, precision, accuracy, LOD, LOQ and robustness in accordance with ICH guide

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MacFarlane, Gordon D., Daniel G. Scheller, Diana L. Ersfeld, et al. "Analytical Validation of the PRO-Trac II ELISA for the Determination of Tacrolimus (FK506) in Whole Blood." Clinical Chemistry 45, no. 9 (1999): 1449–58. http://dx.doi.org/10.1093/clinchem/45.9.1449.

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Abstract Background: The analytical validation of multiple lots of the PRO-TracTM II ELISA (DiaSorin) for the determination of tacrolimus in whole blood is described. Methods: The analytical parameters assessed included analytical sensitivity, dilution linearity, functional sensitivity, values in samples containing no tacrolimus, intra- and interassay precision, supplementation and recovery, metabolite cross-reactivity, interference studies, and method comparisons HPLC-tandem mass spectrometry (HPLC/MS/MS) and the IMx® Tacrolimus II multiparticle enzyme immunoassay. Where appropriate, assessme

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Arla, Rambabu, Srinivasa Rao J, and Kailasam Koumaravelou. "Quantitative determination and validation of ethylhexylglycerin using Gas chromatography method." International Journal of Research in Pharmaceutical Sciences 9, no. 1 (2018): 30. http://dx.doi.org/10.26452/ijrps.v9i1.1154.

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Ethylhexylglycerin, an alkyl glyceryl ether, used in various cosmetics and deodorants is also known to have anti-microbial activity and hence used as an adjuvant along with other preservatives to produce synergistic effect. In the present study, a gas chromatographic method has been employed and validated to determine the presence of impurities along with ethylhexylglycerin. A column having the dimension of DB-1 30m x 0.32mm; 0.25µm with acetone as solvent was found to be optimal for the ideal separation of ethylhexylglycerin from its impurities. Injection volume was set to 1 µl and temperatur

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Shashi, Daksh, and Goyal Anju. "Analytical Method Development and Validation: A Review." Chemistry Research Journal 5, no. 3 (2020): 173–86. https://doi.org/10.5281/zenodo.12589409.

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<strong>Abstract </strong>This review focuses on approach to the validation of HPLC method with the compliance of restrictive needs and accepted pharmaceutical practices. The information during this review provides the explanations for performing analytical method validation. The validation parameters needed to be performed in validation for assay and organic impurities strategies. Individual validation parameters are mentioned in reference to the kind of method such assay and organic impurities method to be valid. This review was written to assist chemists/analysts to perform for method valid

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Godge, Rahul K., Soniya S. Satpute, and Magar M. Sagar. "Development and Validation of Analytical Method for Simultaneous Estimation of Formoterol Fumarate Dihydrate and Fluticasone Propionate from Bulk and Dry Powder Inhaler Formulation." Journal of Drug Delivery and Therapeutics 9, no. 3-s (2019): 212–22. http://dx.doi.org/10.22270/jddt.v9i3-s.2827.

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A method was developed and validated for analysis of Formoterol Fumarate and Fluticasone Propionate in dry powder inhaler formulations. Separation was achieved on a HiQ Sil C18HS, 250×4.6 mm, 5 µm column using a mobile phase consisting of Acetonitrile: 0.01 M Ammonium Dihydrogen Phosphate solution (80:20 %v/v) at a flow rate of 1ml/min PDA detection at 215.0 nm. This method is validated according to ICH guidelines, which include linearity, precision, accuracy, specificity, robustness. The result obtained were within the acceptance criteria as per ICH guidelines. Keywords: formoterol fumarate d

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Satpute, Soniya S., P.D. Dighe, Rahul K. Godge, Arshu A. Patel, and Kiran K. Shinde. "Development and Validation of Analytical Method for Simultaneous Estimation of Formoterol Fumarate Dihydrate and Fluticasone Propionate from Bulk and Dry Powder Inhaler Formulation." Journal of Advances in Bio- pharmaceutics and Pharmacovigilance 1, no. 2 (2019): 9–33. https://doi.org/10.5281/zenodo.3361994.

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<em>A method was developed and validated for analysis of Formoterol Fumarate and Fluticasone Propionate in dry powder inhaler formulations. Separation was achieved on a HiQ Sil C18HS</em><em>, 250×4.6mm</em><em>, 5µm column using a mobile phase consisting of Acetonitrile: 0.01 M Ammonium Dihydrogen Phosphate solution (80:20 %v/v) at a flow rate of 1ml/min PDA detection at 215.0 nm. This method is validated according to ICH guidelines, which include linearity, precision, accuracy, specificity, robustness. The result obtained were within the acceptance criteria as per ICH guidelines.

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Dr., A. Madhukar *. Juveriya Asrar Mariyam Adiba Sultana Shehnaz Begum. "A SIMPLE UV-SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF CARVEDILOL IN BOTH BULK AND MARKETED DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 03 (2019): 6920–25. https://doi.org/10.5281/zenodo.2616682.

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<em>The present work was to develop two simple UV spectrophotometric methods for simultaneous estimation of Carvedilol (CAR) in bulk and tablet dosage form and validate as per ICH guidelines. In this method the absorption maxima was scanned from 200 – 400 nm and the λmax was found to be 248 nm was selected for analysis of Carvedilol. Linearity was observed in the concentration range 1-12μg/ml (r2 =0.9992) for the method. The % assay for the marketed formulation for absorption maxima and area under the curve method was found to be 100.69% and 100.82% respectively. The methods we

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Onjia, Antonije, Tatjana Vasiljevic, Djuro Cokesa, and Mila Lausevic. "Validation of chromatographic analysis." Chemical Industry 56, no. 2 (2002): 76–79. http://dx.doi.org/10.2298/hemind0202076o.

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The parameters for the development of a chromatographic (HPLC) method and its validation are discused in the paper. Chromatographic analysis involves a multi-step procedure consisting of sample collection, pretreatment instrumental measurements and data processing. Emphasize was placed on the instrumental part of the analysis presuming that the contributions of the other variables were minor. The roles of precision, accuracy, detection limit, quantification limit, specificity, selectivity, range, linearity and robustness, as well as system suitability in the analytical application of chromatog

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Banothu, Bhadru* Tadikonda Rama Rao Arukala Bhavani. "Stability Indicating Analytical Method Development And Validation Of Carbamazepine Using UV Spectroscopy." International Journal in Pharmaceutical Sciences 2, no. 9 (2024): 1374–80. https://doi.org/10.5281/zenodo.13851427.

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A novel Spectrophotometric method for quantifying carbamazepine in pharmaceuticals has been developed and validated per ICH Q2 (R1) guidelines. The maximum absorption wavelength was identified at 285 nm in a 0.1N NaOH solution, with a regression coefficient of 0.999, confirming adherence to Beer's Law within a 2–10 μg/ml concentration range. Calibration curves demonstrated linearity, and quality control standards showed accuracy, precision, and robustness, with recovery percentages between 99.2% and 100.8%. The method exhibited low relative standard deviation (RSD) values, with intra-

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Dr., A. Madhukar *. Gariganti Swathi 1. Tanveer Fatima 2. Amina Fatima 2. Madhia Nikhat 2. Mohd Akram Mohsin 2. "A Simple Method Development and Validation for the Determination of Tolbutamide in Bulk and Marketed Dosage Form by UV - Spectrophotometric Technique." Journal of Pharma Research 9, no. 7 (2020): 6. https://doi.org/10.5281/zenodo.3931525.

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ABSTRACT The present work was to develop simple UV spectrophotometric methods for estimation of Tolbutamide (TOL) in bulk and tablet dosage form and validate as per ICH guidelines. In this method the absorption maxima was scanned from 200 – 400 nm and the λmax was found to be 248 nm was selected for analysis of Tolbutamide. Linearity was observed in the concentration range 1-12μg/ml (r2 =0.9992) for the method. The % assay for the marketed formulation for absorption maxima and area under the curve method was found to be 100.49% and 100.78% respectively. The methods were validat

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Yohan, Talari, and Sunitha Reddy M. "A Brief Study on Forced Degradation Studies with Regulatory Guidance." A Brief Study on Forced Degradation Studies with Regulatory Guidance 8, no. 10 (2023): 8. https://doi.org/10.5281/zenodo.10021615.

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Forced degradation studies is a stability indicating analytical method to identify the pathway of degradation of both drug molecule and product by applying various stress testing conditions than accelerated conditions. As stress degradation study is made compulsory by various countries food and drug agencies for regulatory and market approval of both "Branded drugs and Generic drugs" and products respectively. After introduction of ICH guidelines in 1993, worldwide attention gained by stress degradation evaluation report. Hence we provide a brief overview on the force degradation procedure, me

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P., Hari Sravanth Reddy *. Anusha Kota Syed Muneer. "METHOD DEVELOPMENT AND VALIDATION OF NEW RPHPLC METHOD FOR THE ESTIMATION OF PAROXETINE IN PHARMACEUTICAL DOSAGE FORM." Indo American Journal of Pharmaceutical Sciences 04, no. 07 (2017): 2151–63. https://doi.org/10.5281/zenodo.837292.

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Present study aims to develop rapid, greater sensitivity and faster elution by RP-HPLC method for the estimation of Paroxetine. The developed method will be validated in terms of accuracy, precision, linearity, robustness and ruggedness, and results will be validated statistically according to ICH guidelines. The scope of developing and validating analytical methods is to ensure suitable methods for a particular analyte of more specific, accurate, precise and robust. The main objective for this is to improve the conditions and parameters, which should be followed in the development and validat

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Rudrapal, Mithun, and Nazim Hussain. "Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC." Journal of Drug Delivery and Therapeutics 10, no. 4 (2020): 97–101. http://dx.doi.org/10.22270/jddt.v10i4.4217.

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A simple, precise and accurate RP-HPLC method was developed and validated for the estimation of gemifloxacin in the tablet dosage form. The separation was achieved on a reversed-phase C-18 column (250 x 4.6 mm i.d., 5 µm) using a mobile phase consisting of acetonitrile/acetate buffer of pH 4.5 (70:30 v/v) at a flow rate of 1.0 ml/min and a detection wavelength of 244 nm. The separation was carried out on an isocratic mode at room temperature. The method was validated as per ICH guidelines for linearity, accuracy, precision, robustness, LOD, LOQ and specificity. The developed method showed good

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Dalvi, Sampada D., Pramod L. Ingale, and Sanjay M. Dalvi. "DEVELOPMENT AND METHOD VALIDATION OF STABILITY INDICATING ASSAY METHOD OF DUTASTERIDE BY USING UV-VIS SPECTROSCOPY." INDIAN DRUGS 57, no. 12 (2021): 36–40. http://dx.doi.org/10.53879/id.57.12.11575.

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The objective of the present study was to develop and validate stability indicating method to generate reliable, precise, cost effective UV-VIS spectroscopy method and accurate data for dutasteride regardless of whether it is for acceptance, release, stability or pharmacokinetic study. The solvent used was methanol and the absorption maximum λ max of the drug was found to be at 241nm. A linear response was observed in the range of 1-100µg/ml. Linear regression of absorbance on concentration gave the equation y = 0.0194x + 0.0099 with a regression co-efficient (R2) of 0.997. The method was then

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V V, Wamorkar, C. S. Ramaa, Manjunath S Y, and V. Malla Reddy. "Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Voriconazole in Bulk Drug." International Journal of Pharmaceutical Sciences and Nanotechnology 3, no. 2 (2010): 978–86. http://dx.doi.org/10.37285/ijpsn.2010.3.2.11.

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RP-HPLC method has been developed and validated for the determination of voricaonazole in bulk drug. The developed method is found to be specific, reproducible, and stability indicating. The Hypersil, C18 (250 X 4.6 mm) 5μ column was used and mobile phase consisting of water:acetonitrile to achieve good resolution and retention of the analyte and its impurities. The detector linearity was established from concentrations ranging from 5-100 μg/ml. The method was tested at different levels of specificity and accuracy as per requirements given in ICH guidelines. The molecule was exposed to the str

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Poonam, D. Dighe, S. Wakale Vijay, .G.Y Dama, et al. "Assay Method Development and Validation for Simultaneous Estimation of Mometasone Furoate and Azelastine HCL for Nasal Spray by RP-HPLC." Journal of Pharmaceutical Quality Assurance and Quality Control 1, no. 2 (2019): 1–22. https://doi.org/10.5281/zenodo.3040688.

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<em>A simple, precise, accurate, method was developed and validated for analysis of Mometasone Furoate and Azelastine Hydrochloride in nasal spray formulations. For development, different chromatographic condition and stress conditions like acid, base, peroxide, thermal and humidity as per ICH guidelines were used. Method was developed on reversed-phase C<sub>18</sub> column using a mobile phase consisting of potassium dihydrogen, phosphate buffer and acetonitrile. Other HPLC parameters were flow rare 1 ml/min, detection wavelength 239 nm, injection volume 20 </em><em>µl</em><em> and col

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Prajapati, Pintu B., Navneet Wankhed, and Priti J. Mehta. "A Review on Multi Approaches for Impurity Isolation and its Characterization." Journal of Drug Delivery and Therapeutics 9, no. 4-A (2019): 793–802. http://dx.doi.org/10.22270/jddt.v9i4-a.3627.

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International Conference on Harmonization (ICH) has formulated different guideline regarding the control of impurities. In this review, the impurity sources, classification, isolation, detection and characterization methods are described. The some impurities are unavoidable and will be present in trace amounts hence ICH guidelines frame the different policies and establish the specification limits, isolation and characterization is necessary for evaluation and control of impurities. The other regulatory bodies and drug development authorities look up to these guidelines for launching a quality

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Sri K., Bhavya, Hema B., Sumakanth M., and Anil Damarancha. "TWO SENSITIVE CHROMAGENIC METHOD DEVELOPMENT AND VALIDATION OF MOLNUPIRAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM." INDIAN DRUGS 62, no. 02 (2025): 68–77. https://doi.org/10.53879/id.62.02.14451.

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Molnupiravir is an antiviral medication which is utilized to treat COVID-19. Mechanism of action involves increasing the occurrence of mutations in viral RNA, which subsequently hampers the replication of SARS-CoV-2 in humans. This study focuses on the visible method development & validation for analyzing molnupiravir in bulk & dosage form using visible spectroscopy. To assess the chromogenic properties of molnupiravir, different reagents were employed. Notably, a color change was observed with the FC reagent and MBTH reagent. An ELICO SL-210 UV-Visible spectrometer was employed in thi

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Dipak, R. Borase* Vilas. L. Badgujar Nitin. L. Shirole Charushila P. Ahire Harshada Pawara. "Analytical Method Development, Validation Of Pitolisant Drug By Using RP-HPLC Method." International Journal in Pharmaceutical Sciences 2, no. 8 (2024): 2784–93. https://doi.org/10.5281/zenodo.13273666.

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Attempts to develop a robust RP-HPLC method for estimating Pitolisant in tablet form were made using an Agilent (S.K) Gradient System with a UV Detector. The C18 column employed measured 250 mm x 4.6 mm with a particle size of 5 μm. The mobile phase consisted of methanol and 0.1% water with OPA in a 45%:55% v/v ratio. Detection was carried out at a wavelength of 266 nm with a flow rate of 0.8 ml/min. The retention times for Pitolisant were found to be 3.934 and 4.627 minutes. The method was validated in accordance with ICH guidelines, demonstrating linearity over the range of 5-25 μg/ml,

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Bandaru, Nagaraju, Naga Venkata Indira Devi Jajula, Prashik B. Dudhe, et al. "Stability Indicating RP-HPLC Method Development and Validation for Quantification of Favipiravir and its Related Substances." INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 15, no. 03 (2024): 1449–54. http://dx.doi.org/10.25258/ijpqa.15.3.55.

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Background: Favipiravir is an influenza antiviral medication. DEM Avigan is the commercial name for a pyrazine carboxamide derivative. Aim: According to the guidelines framed by ICH - International Council for Harmonisation, the present method was developed and validated for the system suitability, specificity, linearity, precision, limit of quantification and limit of detection, accuracy, & robustness. Results: All the results obtained were within the acceptable range. This method was used to better separate the peaks of Favipiravir and its three impurities. The retention times and square

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T., S. Kamble. "High Performance Thin Layer Chromatography: Method Development and Validation for Estimating the Gallic Acid from Syzygium Cumini Seeds." International Journal of Pharmacy and Biological Sciences (IJPBS) 13, no. 3 (2023): 191–200. https://doi.org/10.5281/zenodo.10648678.

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AbstractIn the current research work, an effective, efficient, exact, easy-to-follow, and trustworthy method was developed for the estimation of gallic acid content from Jamun seed powder. In this research, HPTLC technique is used for analysis along with other quality control test parameters. The preliminary studies by virtue of solubility studies, FT-IR spectroscopy, melting point determination, etc. Working wavelength was determined by UV-Visible spectroscopy. The analytical method development was done for gallic acid estimation in Jamun seed powder, using HPTLC following its validation usin

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Vikas, Chougule, Rajmane Manjiri, Chougule Nilesh, Desai Abhishek, Rohile Vinayak, and Inamdar Nasruddin. "Development Of Reverse-Phase High-Performance Liquid Chromatographic and UV-Spectrophotometric Method with Validation For Octenidine Dihydrochloride." American Journal of PharmTech Research 12, no. 3 (2022): 179–88. https://doi.org/10.5281/zenodo.7106700.

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ABSTRACT The purpose of this research is to develop and validate a precise method for UV-Vis spectrophotometric and Reverse-Phase High Performance Liquid Chromatography (RP-HPLC) for determination of Octenidine dihydrochloride in bulk and pharmaceutical preparation. According to the relevant experiment the maximum wavelength was found to be 285nm and it is used for further process of development of method and its validation. The developed methods used for quantitative estimation of Octenidine dihydrochloride in pharmaceutical preparation and bulk drug which shows the satisfactory results as pe

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Bhale, Sonal. "The ICH guidelines in practices: Stress degradation studies on botulinum toxin and validation of developed stability-indicating HPLC method." Journal of Pharmaceutical and Biological Sciences 10, no. 2 (2023): 68–71. http://dx.doi.org/10.18231/j.jpbs.2022.013.

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A fast, simple, reliable and accurate RPHPLC analytical method was developed for the evaluation of botulinum toxin, and the developed method was subsequently validated according to ICH guidelines in sterile dosage form for stability studies. A C18 column with a flow rate of 2 ml/min was selected. The mobile phase chosen consisted of sodium phosphate buffer (0.05 M) at pH 2.8 and acetonitrile in a ratio of 30:70 respectively at 214 nm. Measured at an Rt of 2.1 min. 10 minutes running time. Linearity and range were observed at concentrations from 1 µg/ml to 10 µg/ml. The method developed was lin

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Kulkarni, Pankaj N., C. K. Jadhav, A. S. Nipate, Alaknanda M. Dodake-Supekar, and C. H. Gill. "Stability Indicating RP-HPLC Method Development and Validation for Dexamethasone." Asian Journal of Chemistry 32, no. 3 (2020): 587–91. http://dx.doi.org/10.14233/ajchem.2020.22462.

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A new, simple, reliable and reproducible stability indicating RP-HPLC assay method has been developed for quantitative analysis of dexamethasone from dexamethasone tablets. This developed method has been validated according to ICH guideline with respect to system suitability, specificity, precision, linearity, accuracy and robustness. An isocratic condition of mobile phase water (0.1% orthophosphoric acid):acetonitrile in a ratio of 60:40, v/v at a flow rate of 1.0 mL/minute over RP 2.5 Fortis C18, 100 × 4.6 mm, 2.5 μm, column was at 27 ºC maintained. This method is specific and showed excelle

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Gowri, Manoja Mulagada* S. Sridevi M. Gayathri Devi Mukalla Ganesh Kumar. "RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF NIACIN AND SIMVASTATIN IN TABLET DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 02 (2018): 1007–12. https://doi.org/10.5281/zenodo.1183739.

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A simple RP-HPLC method has been developed for the simultaneous estimation of Niacin and Simvastatin in tablet dosage form. Chromatographic separation was achieved on Hypersil BDS C18 (250 x 4.6 mm, 5µm column using Acetonitrile and Ammonium dihydrogen phosphate buffer in the ratio of 80:20 v/v, pH 5, with flow rate of 1 ml/min. The detection wavelength was set at 254 nm. The retention time of niacin was 2.0852 and simvastatin was found to be 5.7052. The method was applied to tablet dosage forms, without any interference from excipients. The calibration curve was linear over the range of

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Kumar, Anil, Dilip Agarwal, and Mukesh Bansal. "Method Development and Validation of A Novel Anti-Depressant Bupropion by RP-HPLC." Asian Journal of Pharmaceutical Research and Development 8, no. 3 (2020): 211–24. http://dx.doi.org/10.22270/ajprd.v8i3.720.

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A speedy, simple and precise RP-HPLC process was developed for the estimation of novel antidepressant drug bupropion with Waters X – Bridge C-18 5µm, 4.6 X 150 mm columnusing mobile phase Acetonitrile: Ammonium bicarbonate (5mM) pH-9 adjusted with 1% Ammonium hydroxide (50:50, %v/v).The flow rate was 1 ml/min and quantification was done by PDA detector at wavelength254nm.The Bupropion eluted from the column in 5.194 min. The validation was carried out in the light of ICH guidelines with respect to parameters linearity, specificity, accuracy, limit of detection (LOD) and limit of quantification

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