STABILITY INDICATING RP-HPLC PDA ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF BESIFLOXACIN HYDROCHLORIDE IN BULK AND FORMULATION

Abstract

The goal of the study was to provide an overview of the technique development and validation of a stability-indicating HPLC approach for routine analysis of besifloxacin hydrochloride in pharmaceutical product (ophthalmic suspension). HPLC method was development on octadecasilyl silica (C18, 250 mm x 4.6 mm x 5µ) column at 37 °C and isocratic mode with a running solvent (phosphate buffer: methyl alcohol 40:60 % V/V) using flow rate (1.0 mL minute-1) and UV wavelength 292 nm. Proposed method was validated for specificity, linearity, accuracy, precision, range and robustness according to ICH Q2 (R1) standards. The collected results attest to the validated method’s compliance with the set acceptance standards. Besifloxacin hydrochloride was subjected to hydrolytic, oxidative, thermal and photolytic stress conditions. These samples were then examined using our suggested approach. Hence, this method can be used for routine use for determination assay of besifloxacin hydrochloride drug substance (API) and drug product (ophthalmic suspension).