Development of visible spectrophotometric method and its validation for dolutegravir in tablet dosage form Pawar Vijaykumar T.1, Magadum Mrunalee D.2,* 1Assistant Professor, Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Kolhapur - 416013, Maharashtra, India 2Student, Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy, Kolhapur - 416013, Maharashtra, India *Corresponding Author E-mail: magadummrunalee@gmail.com
Online Published on 23 January, 2024. 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. Top Keywords Dolutegravir, Method development, Validation, Spectrophotometry, HIV, Ferric chloride, Potassium ferricyanide. Top |