Development and Validation of Stability Indicating Hplc Method for Quantification of Dolutegravir Sodium in Bulk as Well as Pharmaceutical Dosage Form

Abstract

Objectives: The aim and objective of this research paper is the development and validation of a rapid, simple, sensitive, precise and specific stability-indicating high-performance liquid chromatographic (HPLC) method for the quantitative estimation of dolutegravir sodium in bulk drug and pharmaceutical dosage form.

Methods: The chromatographic separation was achieved on the Thermo Fischer Scientific C8 Synchronis (150x4.6mm, 5µm) using isocratic mode. Mobile phase composed of a mixture of Buffer: ACN in the ratio of 60:40 v/v at the flow rate of 1mL/min. The wavelength of detection is 258 nm. The retention time of DTG was 6.60.

Results: The proposed method shows a good linearity in the concentration range of 80–120% for DTG. Precision and recovery study results are in between 98 and 102%. In the entire robustness conditions, percentage relative standard deviation is <2.0 %. The peak for dolutegravir sodium was observed at 6.0±1.0 minutes. This method is validated for different analytical performance parameters like linearity, precision, accuracy, limit of detection, limit of quantification and robustness 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. The developed method is stability indicating, precise and specific which can be applied for the routine quality control analysis of dolutegravir sodium.