Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AMINOCAPROIC ACID IN PHARMACEUTICAL DOSAGE FORMS

Miral Patel*, Dharti Patel, Dr. Sumer Singh, Dr. Keyur Ahir

ABSTRACT

A simple, Accurate, precise method was developed for the simultaneous estimation of the Aminocaproic acid in Tablet dosage form. Chromatogram was run through ACE-5-C18, (250 x 4.6 mm), 5. Mobile phase A containing Buffer solution and Mobile phase B Acetonitrile in the gradient programme was pumped through column at a flow rate of 1ml/min. Buffer used in this method was 2.70 g Potassium dihydrogen phosphate, 2.0 g of Hexane-1-sulfonic acid sodium salt and 1.0mLof Triethylamine buffer with pH 2.50 adjusted by Orthophosphoric acid. Optimized wavelength for Aminocaproic acid was 210 nm. Retention time of Aminocaproic acid was found about 6.2 minutes, linearity range was 124.411 μg/ml to 1119.705 μg/ml. The new method was evaluated according to ICH guideline and as far as validation results are concern correlation coefficient value was 1.00 for the very compound, percentage recovery 99.6%, repeatability results relative standard deviation (%RSD) 0.0 for Aminocaproic acid. The developed HPLC method was found to be a simple and rapid one for regular analysis in professional laboratory.

Keywords: Aminocaproic acid, Method Development, Validation, RP-HPLC.