Development and Validation of HPLC with UV Detection Method: Analysis of Cilazparil in Pharmaceutical Dosage Forms

Abstract

A simple and rapid liquid chromatographic method was developed and validated for the determination of cilazapril (CZP) in bulk drug and pharmaceutical dosage form. Chromatographic separation has been achieved within 10 minutes by using an Cyano column (150 mm × 4.6 mm I.D., 5 μm particle size) as the stationary phase with a mobile phase consisted of formate buffer pH 3.75 and methanol (50:50 v/v) at a flow rate of 1.2 mL/min. Detection was performed at 227 nm using an ultraviolet detector. The method was validated in accordance with International Conference on Harmonization guidelines with respect to linearity, sensitivity, selectivity, accuracy, precision and robustness. Regression analysis showed good correlations (R2=0.9995) for CZP in the concentration range of 2-200 μg/mL. The percentage recovery was in the range of 99.20%-99.96% for CZP from the pharmaceutical dosage form. The proposed method is suitable for determination of CZP in pharmaceutical dosage form and bulk drug.