ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR AMLODIPINE BESYLATE AND LISINOPRIL IN COMBINED TABLET DOSAGE FORM BY USING SIMULTANEOUS ESTIMATION METHOD

Abstract

The purpose of this study was to develop and validate a simple, sensitive, accurate, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for simultaneous estimation of amlodipine besylate and lisinopril in a Tablet dosage form. The chromatographic measurement was performed on a Phenomenex C18 (250 × 4.6 mm, 5um) column with an optimised Acetate buffer mobile phase: Methanol (65:35). The flow rate was one ml/min, and the detecting wavelength was 221 nm. Triethanolamine was used to adjust the pH to 5. In the concentration range of 4-20 ug/ml, amlodipine besylate and lisinopril showed a linear response of the suggested approach. The correlation coefficients ('r' values) for amlodipine besylate and lisinopril were 0.9998 and 0.9995, respectively, and the retention times were 3.279 for amlodipine besylate and 6.124 for lisinopril, respectively. The developed chromatographic technique was validated for specificity, linearity, precision, accuracy, LOD, and LOQ using ICH Q2(R1) criteria. The analysis results have been validated in accordance to ICH guidelines