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A simple, accurate, robust, specific and precise Reverse phase HPLC method was developed for the simultaneous estimation of the Enalapril maleate and Losartan potassium in pure and pharmaceutical dosage form as per ICH Guidelines. Chromatogram was run through Phenomenex Luna C18 (4.6 mm×150 mm, 5 µm) Particle size column and of Methanol: TEA Buffer pH-4.8 (35:65) v/v at a flow rate of 1.0 ml/min. Temperature was maintained at 38°C. Optimized wavelength selected was 276 nm. Retention time of Enalapril maleate and Losartan potassium were found to be 2.090 min and 5.289 min. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification. The proposed method optimized and validated as per ICH guidelines. The method is validated as per ICH guideline by determining its specificity, accuracy, precision, linearity & range, ruggedness, robustness and system suitability.The results of the study show that the proposed method is simple, rapid, precise and accurate, which is useful for the routine determination of Enalapril maleate and Losartan potassium in bulk and tablet dosage forms. The method could be applied for determination of in its tablet dosage forms without any interference from excipients or endogenous substances. The proposed method is suitable for routine quality control analysis.


Enalapril maleate Losartan potassium RP-HPLC Validation ICH Guidelines

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