Asian Journal of Pharmaceutical Analysis
  • Year: 2026
  • Volume: 16
  • Issue: 1

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

  • Author:
  • Shweta Sinha1, Jitendra Yadav1, Dolly Dewangan1, Kamraj1, Krity Gupta1, Manish Kumar Sahu1, Parimal Verma1, Prashant Kumar Sahu1, Aakanksha Sinha1, S. J. Daharwal1
  • Total Page Count: 7
  • Page Number: 14 to 20

1University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur (C.G)

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.

Keywords

CLOP, Zero order spectrophotometric (D°), AUC (Area under Curve), First order derivative spectrophotometric (D1), LOD and LOQ