Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DOLUTEGRAVIR IN BULK AND DOSAGE FORM

Jyoti Sonawane, Siddiqua Shaikh*, Sonali Suryawanshi, Sharda Gangurde and Gayatri Wagh

ABSTRACT

Objective: The present paper describes a simple, accurate, and precise reversed-phase high-performance liquid chromatography (HPLC) method for rapid and simultaneous quantification of dolutegravir (DTG) in bulk and pharmaceutical dosage form. Methods: The chromatographic separation was achieved on C18 (250mmx4.6mm, 5μ id). Mobile phase contained a mixture of methanol: water in the ratio of 80:20 v/v, flow rate 1.1ml/min and ultraviolet detection at 258 nm. Results: The retention time of DTG was 2.75 min. The proposed method shows a good linearity in the concentration range of 15–55 μg/ml for DTG under optimized conditions. Precision and recovery study results are in between 98 and 102%. In the entire robustness conditions, percentage relative standard deviation is. Conclusion: This method is validated for different analytical performance parameters like linearity. Precision, accuracy, limit of detection, limit of quantification, robustness, and pharmacokinetic study were determined according to the International Conference of Harmonization (ICH) Q2B guidelines. All the parameters of validation were found in the acceptance range of ICH guidelines.

Keywords: Reversed-phase high-performance liquid chromatography, Dolutegravir.