Development and Validation of HPTLC Method for the Estimation of Repaglinide in Bulk and Tablet Dosage Form

About author
Dhirender Singh*, Pradeep Kumar, Pravesh Kumar
School of Pharmacy, Suresh Gyan Vihar University, Jaipur,Rajasthan, India
Shri Gopichand College of Pharmacy, Baghpat, Uttar Pradesh, India

Abstract
A simple, accurate, precise, and rapid high performance thin layer chromatographic method has been developed and validated for the estimation of repaglinide in tablet dosage forms. The method employed TLC aluminium plates precoated with silica gel 60 F 254 as the stationary phase. The mobile phase used was a mixture of Chloroform: Methanol (9:1) v/v. The detection of spot was carried out at 254 nm. The calibration curve was found to be linear between 300 to 3000 ng mL^-1 Rf value 0.41±0.018 with regression coefficient of 0.9991. The proposed method can be successfully used to determine the drug content of marketed formulation. The accuracy of the proposed method was determined by recovery studies and found to be 97.98 to 98.89 %. The proposed method is applicable to routine analysis of repaglinide  in bulk and pharmaceutical formulations. The proposed method was validated according to various ICH parameters like linearity, accuracy, precision, specificity, limits of detection, limits of quantification, range and solution stability.
Key words: Repaglinide, HPTLC, ICH guidelines