Development and Validation of New Analytical Method for the Simultaneous Estimation of Lisinopril and Amlodipine in Pharmaceutical Dosage Form by UV Spectrophotometry

Pavan Kumar.V*, P. Jyoshna, P. Nageena, E. Sandhya Mahalakshmi, K. Siva Kumar, A. Subha Jahnavi, A. Tharun Sai
Department of Pharmaceutical Analysis, Seven Hills College of Pharmacy, Venkatramapuram, Tirupati-517561     

A B S T R A C T
An elementary, valid, Speedy and decisive strategy was developed to determine Lisinopril and Amlodipine quantitatively in combined pharmaceutical dosage forms. The method was based on UV-Spectrophotometric determination of two drugs using simultaneous equation method. It involves absorbance measurement at 290 nm (λ_max of Lisinopril) and 287 nm (λ_max of Amlodipine) in Methanol: Acetonitrile (30:70 v/v). For UV Spectrophotometric method, linearity was obtained in concentration range of 1-15 mcg/ml for Amlodipine and 1-50 mcg/ml for Lisinopril respectively with regression 0.999 and 0.998 for Amlodipine and Lisinopril respectively. Recovery was in the range of 98 -102%. The acceptance criteria of precision was Relative variance should be less than 2.0% and also the strategy showed precision less than 2.0 % for both Lisinopril and Amlodipine which shows that the tactic was precise in accordance with ICH guidelines. The method has been successively applied to pharmaceutical formulation and was validated according to ICH guidelines. The proposed method has been applied to formulation without interferences and specific for the estimation of Lisinopril and Amlodipine simultaneously.
Keywords: UV-spectrophotometer, Lisinopril, Amlodipine, Linearity, Validation, Precision