METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF AMLODIPINE AND ENALAPRIL MALEATE IN ACTIVE PHARMACEUTICAL INGREDIENT AND COMBINED TABLET DOSAGE FORM BY RP-HPLC

Dr. A. Yasodha, G. Anuhya Goud, G. Surekha and L. Bhargavi*

ABSTRACT

Objective: A simple, Accurate, precise method was developed for the simultaneous estimation of the Amlodipine besylate and Enalapril maleate in pharmaceutical dosage form. Methods: Chromatogram was run through Altima C18. Mobile phase containing Methanol: TEA Buffer pH 4.5: Acetonitrile (50:25:25) was pumped through column at a flow rate of 1ml/min. Temperature was maintained at Ambient. Optimized wavelength for Amlodipine besylate and Enalapril maleate was 350 nm. Run time was selected to be 7 min because analyze gave peak around 2.102, 3.537 ±0.02min respectively and also to reduce the total run time. Results: Retention time of Amlodipine besylate and Enalapril maleate were found to be 2.120 min and 3.536 min. The % purity of Amlodipine besylate and Enalapril maleate was found to be 99.6 % and 99.6 % respectively. The system suitability parameters for Amlodipine besylate and Enalapril maleate such as theoretical plates were found to be 5432 and 5987. The linearity study for Amlodipine besylate and Enalapril maleate was found in concentration range of 15-25 μg and 10 μg-50 μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 99.6 % and 100 %, %RSD for repeatability was 0.42 and 0.18 %. The precision tudy was precise, robust and repeatable. LOD value was 0.2, 2.3 and LOQ value was 0.8 and 7.04 respectively. Conclusion: The results of study showed that the proposed HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Amlodipine besylate and Enalapril maleate in pharmaceutical dosage form.

Keywords: Amlodipine besylate, Enalapril maleate, HPLC, Simultaneous estimation.