Development of Visible Spectrophotometric Method and its Validation for Dolutegravir in Tablet Dosage Form

Abstract

Objective: There are several methods for analyzing the same, however, they are time-consuming and costly. We created a new spectrophotometric method for determining Dolutegravir (DLT) in tablet dosage forms that is simple, accurate, and precise. We developed and validated a simple, accurate, and precise colorimetric method for the quantitative analysis of Dolutegravir in bulk and dosage form by ICH recommendations in this study. Methodology: There are several methods for analyzing the same, however, they are time-consuming and costly. We created a new spectrophotometric method for determining Dolutegravir (DLT) in tablet dosage forms that is simple, accurate, and precise. In methanol, the initial stock solution of Dolutegravir was prepared. The method is based on the formation of a blue color chromogen complex from Dolutegravir oxidation-reduction with Ferric chloride in the presence of potassium ferricyanide. Result: The color complex was measured at 710nm. Beers law was observedin the concentration range of 3.5-6.5μg/ml witha coefficient of correlation (R2) was 0.998. The system suitability criteria were found to be within the limits. The LOD and LOQ were found to be 0.91 and 2.47, indicating that the method is sensitive. Conclusion: The relative standard deviation (RSD) and percent recovery values were found to be satisfactory, indicating that the proposed method is suitable, accurate, and precise and that it can be used in routine analysis of Dolutegravir in tablet dosage forms, with relatively low-cost solvents.