Validation of the UV Spectrophotometric Method for the Quantitative measurement of Clopidogrel bisulphate in Pharmaceutical Dosage Form and Bulk

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Authors: Shweta Sinha, Jitendra Yadav, Dolly Dewangan, Kamraj Kamraj, Krity Gupta, Manish Kumar Sahu, Parimal Verma, Prashant Kumar Sahu, Aakanksha Sinha, Sanjay J. Daharwal
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References: 12

Abstract

For the quantitative determination of clopidogrel bisulphate in bulk and pharmaceutical dose forms, a straightforward, accurate, precise, and economical approach has been established. Methanol (a co-solvent) and 0.05 N acetic acid (a solvent) were used to create the standard and sample solutions. Area Under Curve (AUC), Zero order, and First order derivative are the three UV spectrophotometric methods that were developed. The zero order technique showed linearity at 270 nm over 10–100µg/ml with R² = 0.9992. The first derivative methodology yielded R² = 0.9996 at 244nm and 281nm (R² = 0.9987), whereas the AUC method yielded R² = 0.9994 at 265–275nm. For criteria including linearity, accuracy, precision, LOD, and LOQ, all techniques were validated in accordance with ICH guidelines. Precision studies showed that the percentage relative standard deviation was within acceptable boundaries. The results confirmed that all of the suggested methods are simple, sensitive, accurate, and suitable for routine drug screening in pharmaceutical formulations.

Fields of Study & Subjects

Analytical Methods in Pharmaceuticals Antiplatelet Therapy and Cardiovascular Diseases Pharmaceutical Quality and Counterfeiting

Publication details

Journal / source
Asian Journal of Pharmaceutical Analysis
Volume
16
Issue
1
Pages
14–14
Publication date
27 January 2026
Language
EN