HPLC METHOD FOR ESTIMATION OF DRUG RELEASE OF SOFOSBUVIR IN PHARMACEUTICAL FORMULATIONAbstract
Pharmaceutical industry and quality control laboratories needs of robust methods for analysis of drugs used in the treatment of life-threatening diseases such as hepatitis C. Using HPLC technique, a rapid, selective, precise and accurate method was developed and validated for the estimation of % drug release of Sofosbuvir in a pharmaceutical formulation. Stability indicating HPLC method was developed using Zorbax eclipse plus C18 (100 × 4.6 mm), 3.5 µ as analytical column and a combination of ammonium acetate buffer pH 5.3 and methanol in the ratio (45: 55) was used as mobile phase in isocratic mode. UV detection was carried out at 260 nm, column temperature was maintained at 25 °C, and the flow rate was 1.5 ml/min. The method was validated as per internationally accepted ICH guideline and found to be specific for blank and placebo solution, precise, robust, accurate and linear in range 9.2 to 69.0 µg/ml of Sofosbuvir. This method can be used for routine analysis of pharmaceutical formulation in any quality control laboratory leading to delivery of good quality healthcare solution.
K. Singh *, S. Bhatt and R. Prasad
Department of Chemistry, Sarvepalli Radhakrishnan University, Bhopal, Madhya Pradesh, India.
27 April 2018
11 July 2018
18 July 2018
01 January 2019