Analytical Method Development and Validation for the Estimation of Ritonavir in Bulk and Pharmaceutical Dosage Form

K. Swapna1, M. Zaheer Ahamed1, M. Renamma1, B. Famida1, B. Mohammed Ishaq1*, Hindustan Abdul Ahad1, Ramesh Dhani2
1Department of Pharmaceutical Analysis, Balaji College of Pharmacy, Anantapur–515001, AP, India.
2Dept. of Pharmaceutical Chemistry, Ratnam Institute of Pharmacy, Nellore, Andhra Pradesh, India-524346
Received: 30 April 2014, Accepted: 6 June 2014, Published Online: 18 July 2014

Abstract
A simple, robust, selective and sensitive spectrophotometric method has been developed for the determination of Ritonavir in pharmaceutical formulations. The method was based on the scanning of the drug in 0.1 N HCl and the same conditions for formulation. The method showed high sensitivity with linearity range from 10 to 60 μg/ml. The limit of detection (LOD) was found to be 1.1 μg/ml and the limit of quantization (LOQ) was determined as the lowest concentration was found to be 3.3 μg/ml. The variables that affected the reaction were carefully studied and optimized.The proposed method was applied successfully for the determination of Ritonavir in pharmaceutical formulations. The percentage recovery was found to be 99.426 ± 0.59 (n = 9) for pharmaceutical formulation.
Keywords: UV spectroscopic, Ritonavir, linearity, precision, ICH guidelines