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Relevant bibliographies by topics / ICH Q2 (R1) Guidelines

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Academic literature on the topic 'ICH Q2 (R1) Guidelines'

Author: Grafiati

Published: 3 June 2025

Last updated: 31 July 2025

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Journal articles on the topic "ICH Q2 (R1) Guidelines"

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B, Deshmukh S., Wagh P. A, Yadav S. S, and Mane M. B. "Stability-Indicating HPLC Method Development and Validation for the Simultaneous Determination of Vildagliptin and Dapagliflozin in Pharmaceutical Dosage Form." INTERNATIONAL JOURNAL OF DRUG DELIVERY TECHNOLOGY 14, no. 03 (2024): 1599–603. http://dx.doi.org/10.25258/ijddt.14.3.49.

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Vildagliptin (VD) and Dapagliflozin (DP) were determined simultaneously by RP-HPLC using an ultraviolet (UV) detector, a Hypersil Gold C18 (250 × 4.6 mm) column, 5 µm and a mobile phase of acetonitrile: water (adjusted with O-Phosphoric acid to pH 3) in ratio 40: 60% v/v. The estimation wavelength was chosen to be 213 nm. VD and DP were shown to have retention times of 2.9 and 8.3 minutes, respectively. Q2 (R1) ICH guidelines were followed during the validation process. VD and DP correlation coefficient R2 values are 0.9993 and 0.999, respectively. While DP’s linearity range is 1 to 6 µg/mL, V

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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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Arun Kumawat, Jaymala, Vivek Kumar, Preeti, et al. "VALIDATION AND EVALUATION OF AN HPLC METHOD FOR QUANTIFICATION OF VITAMIN D3 IN PHARMACEUTICAL FORMULATIONS." Cuestiones de Fisioterapia 54, no. 4 (2025): 919–27. https://doi.org/10.48047/wy5sw824.

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In accordance with the guidelines provided by ICH Q2 (R1), the analytical procedure that you have described for quantifying vitamin D-3 through the use of HPLC is quite comprehensive and has been thoroughly validated. The apparatus appears to be reliable, as it consists of a C-18 column, a mobile phase consisting of methanol and water, and detection at 264 nm, which is an adequate wavelength for vitamin D-3 identification

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Padh, H., S. Parmar, and B. Patel. "DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF SWERTIAMARIN IN BULK AND DOSAGE FORM." International Journal of Applied Pharmaceutics 9, no. 6 (2017): 80. http://dx.doi.org/10.22159/ijap.2017v9i6.22214.

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Objective: In the present study a novel stability-indicating high-performance thin-layer chromatography (HPTLC) method for quantitative determination of Swertiamarin (SW) in bulk drug and formulation has been developed and validated as per ICH guideline Q2 (R1) for global acceptance of standardized herbal formulations.Methods: HPTLC method is developed and validated using solvent ethyl acetate: ethanol: chloroform (3:2.5:4.5 v/v/v) (Rf of SW 0.65±0.04) in the absorbance mode at 243 nm. Various forced degradation conditions were used to check degradation of drug.Results: The method showed a goo

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Mangal, B. Gahandule* Shanker M. Dhobale1. "ESTIMATION OF HYDROCHLOROTHIAZIDE IN BULK AND TABLET DOSAGE FORMS BY AREA UNDER CURVE SPECTROPHOTOMETRIC METHOD." INDO AMERICAN JOURNAL OF PHARMACEUTICAL RESEARCH 07, no. 01 (2017): 7420–25. https://doi.org/10.5281/zenodo.1006947.

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A simple, accurate and precise area under curve method was developed for spectrophotometric estimation of hydrochlorothiazide in pure and tablet dosage forms. “The area under two points on the mixture spectra is directly proportional to the concentration of the component of interest” is the AUC curve. The area selected for estimation of hydrochlorothiazide was between 260 to 280 nm. The method represented regression coefficient (R2 = 0.999) at concentration rang 5-25 μg/ml. Estimation of the drugs was found up to 100 % representing the accuracy of the method. The recovery of the hydrochlorothi

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Gawande, V. T., and K. G. Bothara. "APPLICATION OF EXPERIMENTAL DESIGNS FOR OPTIMIZATION OF FORCED DEGRADATION STUDIES AND DEVELOPMENT OF STABILITY-INDICATING HPTLC METHOD FOR COMBINATION OF CEFPODOXIME PROXETIL AND OFLOXACIN." INDIAN DRUGS 55, no. 07 (2018): 49–58. http://dx.doi.org/10.53879/id.55.07.10851.

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A stability indicating HPTLC method was developed and validated for fixed dose combination of cefpodoxime proxetil and ofloxacin. TLC plates precoated with silica gel 60F254 were used as stationary phase and n propanol: ammonia (7:3 v/v) was used as mobile phase. Densitometric scanning was carried out at 290nm. Specificity of the method was established by peak purity studies. Method was validated as per ICH guidelines Q2 (R1) for accuracy, precision, linearity, sensitivity and robustness. Both the drugs were subjected to hydrolytic (acidic and basic), oxidative, thermal and photolytic stress a

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Venkata Kishore Ch, Tejeswara Rao V, Balaji K, Bala Prasad S, and Annapurna Nowduri. "Quantification of cefixime drug substances in pharmaceutical formulations by analytical GC." Open Access Research Journal of Chemistry and Pharmacy 2, no. 2 (2022): 001–11. http://dx.doi.org/10.53022/oarjcp.2022.2.2.0031.

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The present study was conducted to develop and validate an analytical procedure for the determination of cefixime in Pharmaceutical Formulations. The analytical test attributes and evaluated as per the guidelines of ICH Q2 (R1). The method was validated for the determination of Assay in finished products of cefixime and the method validation parameters were evaluated for the analytical test attribute cefixime meets the acceptance criteria. The results obtained were within the specified limits and the samples were analyzed for test item concentration by Gas Chromatography.

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Ankita, Thaikar* Deepti Bommanal Mayuri Shindhe Rashika Wagger Ujjanagouda Dannappanavar Veeranagoud Patil. "Extraction, Purification and Partial Estimation of Caffeine from Marketed Tea and Coffee Powder." International Journal of Pharmaceutical Sciences 2, no. 12 (2024): 3366–73. https://doi.org/10.5281/zenodo.14575565.

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The objective of present work is to extract, purify and partially estimate caffeinefrom marketed coffee and tea powder.UV-Spectrophotometric method was evolved using chloroform as solvent. The evolved method was standardized in terms of validation parameters such as simple, sensitive, linear as per ICH Q2 (R1). Guidelines for analysis of caffeine in marketed tea and coffee powder.Caffeine was extracted from different brands of marketed coffee and tea powder and was analyzed through different analytical methods like UV-Spectroscopy, Iodometric Titration, Solubility, Melting point, Thin Layer Ch

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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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K, Swamy Sekhar, Venkata kishore Ch, Tejeswara Rao V, and Raghu Babu K. "HPLC method for the development and validation of busulfan in pharmaceutical formulation." GSC Advanced Research and Reviews 6, no. 3 (2021): 136–42. https://doi.org/10.5281/zenodo.4644190.

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A validated HPLC method was developed for the determination of Busulfan (BUS) in pharmaceutical formulation.It is a new simple, accurate, precise and reproducible HPLC method has been developed for the estimation of Busulfan (1,4-butanediol dimethanesulfonate) in its inject able dosage.The method developed in High Performance Liquid Chromatographic method using suitable column (YMC Pack ODS-A (150 x 4.6) mm, 3µm). All the components of the system are controlled using SCL-10Avp System Controller. Data acquisition was done using LC Solutions software.The method was validated as per the ICH

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Book chapters on the topic "ICH Q2 (R1) Guidelines"

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Borman, Phillip, and David Elder. "Q2(R1) Validation of Analytical Procedures." In ICH Quality Guidelines. John Wiley & Sons, Inc., 2017. http://dx.doi.org/10.1002/9781118971147.ch5.

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"Method Validation and Documentation (Procedure 5)." In SIFT-MS. Royal Society of Chemistry, 2025. https://doi.org/10.1039/9781837677917-00281.

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As a chromatography-free analytical technique, selected ion flow tube mass spectrometry (SIFT-MS) speciates and quantifies volatile compounds in the gas phase using a very different approach to traditional laboratory techniques. Nevertheless, as described in this chapter, guidelines for analytical method validation, such as ICH Q2(R1), are readily adapted to both automated headspace-SIFT-MS analysis and less conventional SIFT-MS approaches. Additionally, recommendations are made for documentation of SIFT-MS methods for quality systems and routine use.

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Kasangaki, Wilberforce. "Method Validation and Verification." In Analytical Methods for Drug Development. THINKPLUS PHARMA PUBLICATIONS, 2025. https://doi.org/10.69613/28x3yy16.

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Method validation establishes analytical procedure reliability through systematic performance evaluation. ICH Q2(R1) guidelines provide validation frameworks adaptable across development phases from early research through commercialization. Risk-based approaches align validation effort with method purpose and product criticality. Validation parameters include specificity testing against potential interferents, linearity across concentration ranges, accuracy through recovery studies, precision at repeatability and intermediate levels, detection and quantitation limit determination, and robustne

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Ranjith, K., D. Rama Sekhara Reddy, and TEGK Murthy. "Development and Validation of Stability Indicating Related Substances Method for Montelukast Sodium and Levocetirizine Dihydrochloride Combined Tablets by RP-HPLC." In Current Trends in Drug Discovery, Development and Delivery (CTD4-2022). Royal Society of Chemistry, 2023. http://dx.doi.org/10.1039/9781837671090-00304.

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In this paper authors presented the development and validation of RP-HPLC method for determination of related substances present in Montelukast sodium and Levocetirizine dihydrochloride combined tablets. Chromatographic separation was achieved on Hypersil ODS (150 x 4.6 mm),5 µ column with flow rate 1 mL/min, detection wavelength 238 nm, injection volume 10 µL, column temperature 40°C and run time 75 mins. Gradient programming was used with mobile phase-A (MP-A)-50mM acetate buffer pH 5.5 and mobile phase-B(MP-B)-methanol: MP-A (90:10 %v/v). Developed method was validated as per ICH Q2(R1) gui

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