ANALYTICAL METHOD DEVELOPMENT AND VALIDATION USING RP - HPLC FOR SIMULTANEOUS ESTIMATION OF ENALAPRIL AND LOSARTAN IN BULK SAMPLES AND TABLET DOSAGE FORMS

Objective: A simple, Accurate, precise method was developed for the simultaneous estimation of the Enalapril and Losartan in pharmaceutical dosage form.

Methods: Chromatogram was run through Phenomene x C 18 column (150x4.6mm, 5µm). Mobile phase containing Buffer: ACN:Methanol (30:5:65) pH 3.5 was pumped through column at a flow rate of 1.2 ml/min. Buffer used at pH 3.5. Temperature was maintained at Ambient. Optimized wavelength for Enalapril and Losartan was 249 nm.

Results:  Retention time of Enalapril and Losartan were found to be 5.04 min and 9.71 min. The % purity of Enalapril and Losartan was found to be 100.03 % and 99.75 % respectively. The system suitability parameters for Enalapril and Losartan such as theoretical plates and tailing factor were found to be 4836,0.97 and 3568, 1.42. the resolution was found to be 8.0. The linearity study for Enalapril and Losartan was found in concentration range of 5μg-15 μg and 200 μg-600 μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100.19 % and 100.84 %, %RSD for repeatability was 0.75 and 0.36 %. The precision study was precise, robust and repeatable. LOD value was 0.08 and 0.25, and LOQ value was 1.08 and 0.35 respectively

Conclusion: The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Enalapril and Losartan in pharmaceutical dosage form.

Keywords: Enalapril, Losartan, RP‐HPLC, Simultaneous estimation.