Abstract

DEVELOPMENT AND VALIDATION OF A RP HPLC METHOD FOR ESTIMATION OF CLOPIDOGREL AND ASPIRIN IN BULK AND IN PHARMACEUTICAL DOSAGE FORM

Dhanshri R. Shinde*, Dr. R. B. Laware, Dr. S. B. Dighe and Ankita V. Deodhe

Abstract

The purpose of these work was to develop a simple, rapid, sensitive and validated RP-HPLC method for separation and analysis of Aspirin and Clopidogrel in bulk and tablet dosage form. The separation was conducted by using Grace C 18 (150×4.6μm) with mobile phase consisting of methanol: water in the ratio (90:10) pH4. The mobile phase was delivered at the flow rate of 1.0 ml/min. The eluent was monitored at wavelength 244 nm by UV 3000 wavelength detector and found a sharp and symmetrical peak with retention time for Aspirin and Clopidogrel was found to be 4.474 min and 5.883 min respectively. The method was validated for linearity, accuracy, precision, system suitability, and stability. These method was validate according to ICH guidelines which include linearity, precision, accuracy, robustness, LOD, LOQ. The result obtained were within the acceptance criteria as per ICH guidelines.

Keywords: HPLC, Aspirin, Clopidogrel, Methanol, Water, Validation.