A Stability Indicating RP-HPLC Method for the Determination of Lisinopril and Amlodipine Besylate in Bulk and Combined Pharmaceutical Dosage Form

Author(s): Kharat Sachin Sadanand*, Andhale Saurabh Prakash, Saudagar Ravindranath Bhanudas

Abstract: The simple, selective, accurate, efficient, and reproducible Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for analysis of Lisinopril and Amlodipine besylate in bulk and tablet dosage form. The separation was carried out on Younglin (S.K) Gradient System UV Detector UV 730 D & SP930 D (150 mm x 4.6ID, Particle size: 5 micron) in isocratic mode column using the mobile phase composition was acetonitrile: phosphate buffer (25:75 % v/v) adjusted to pH 3.0 using triethylamine. The injection volume was 20μl at flow rate of 1.0 mL/min, effluent was detected at 211 nm with a sharp peak obtained for Lisinopril and Amlodipine besylate at a retention time of 5.8333 ± 0.01 min and 4.4167 ± 0.01 min resp. Linearity was observed in the concentration range from 05 to 30 μg/mL and 2.5 to 15 μg/mL for Lisinopril and Amlodipine besylate with a correlation coefficient of (r2) 0.9993 and 0.9994, respectively. The recoveries of Lisinopril and Amlodipine besylate were found within limit 98.85-99.28% and 100.48-101.58 %. The percentage relative standard deviation for accuracy and precision was found to be less than 2%. The method was validated according to ‘The International Council for Harmonization’ guidelines in terms of linearity, accuracy, precision, and specificity. Hence, the proposed method can be utilized for routine quality control of Lisinopril and Amlodipine besylate in bulk and tablet dosage form.

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