Abstract

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF SITAGLIPTIN PHOSPHATE IN ACTIVE PHARMACEUTICAL INGREDIENT AND PHARMACEUTICAL DOSAGE FORM

Amar R. Tumbare*, Dr. Navnath B. Shinde, Dr. Rakesh Kumar

ABSTRACT

The purpose of the presented work was to develop a simple, precise and accurate High performance thin layer chromatography (HPTLC) method for the quantitative estimation of Sitagliptin phosphate in its single dosage tablet formulations and Active pharmaceutical ingredient. Chromatographic separation of Sitagliptin phosphate was done on TLC aluminum plates pre-coated with silica gel 60 F254 using mobile phase as n-Butanol: Methanol: Water: Formic Acid 3:1:1:0.1 (v/v/v/v). Scanning of Sitagliptin phosphate was done at absorbance mode at 269 nm using Camag TLC Scanner. Sitagliptin phosphate showed Rf value at 0.60. The Validation of method in term of linearity (2000-7000 ng/spot), Precision (% RSD for Repeatability 1.69%, % RSD for intra-day variation 1.42%, % inter-day variation 0.87%), Accuracy (96.29 -91.85%) and Specificity. The limit of detection and limit of quantification for Sitagliptin phosphate were found to be 1000ng/spot and 2000 ng/spot correspondingly. It is concluded from the results that the proposed High performance thin layer chromatography is simple, inexpensive, accurate and precise and it is useful in routine analysis in Quality control department for estimation of Sitagliptin Phosphate in Pharmaceutical dosage form and Active pharmaceutical ingredient. This method was validated as per ICH guideline Q2 (R1).

Keywords: The purpose of the presented work was to develop a simple, precise and accurate High performance thin layer chromatography (HPTLC) method for the quantitative estimation of Sitagliptin phosphate in its single dosage tablet formulations and Active pharmace