Abstract

INVITRO COMPARATIVE DISSOLUTION STUDY FOR DIFFERENT BRANDS OF SAXAGLIPTIN AND VILDAGLIPTIN TABLETS USING UV SPECTROSCOPY AND THEIR VALIDATION AS PER ICH GUIDELINES

Afsha Fatima, Shaheena Arjumand, Wajiha Azhar, Mohammed Abdul Mateen and S. H. Rizwan*

ABSTRACT

Invitro drug dissolution is an important Quality control parameter in Pharmaceutical discipline used to evaluate the release of drug from tablet dosage form under standard conditions. The present research proposal is a comparative dissolution study for two different brands of majorly used antidiabetic drugs, Saxagliptin and Vildagliptin both belonging to the gliptin category of anti diabetics. Pharmacologically, their anti- diabetic action is attributed to inhibiting DPP- 4 Enzyme to deal with type 2 Diabetes. The aim of this study is to perform Invitro comparative dissolution study for different brands of Saxagliptin and Vildagliptin tablets using UV spectroscopy as the chief analytical technique. The aim of the present research work is to investigate the most preferable dissolution media for drug evaluation. Phosphate buffer of pH 6.8 was selected, prepared and maintained at a temperature of 37±0.5°C and the paddle type II USP apparatus was set at 100 rpm, and aliquots were withdrawn at an interval of 15, 30, 45 and 60 minutes. The absorbance maxima (lamda max) of Saxagliptin tablet was 266 and 264 nm and Vildagliptin tablet was 265 and 263nm. The analytical method was evaluated as per ICH guidelines on accuracy and precision parameters. The intraday precision of Saxagliptin was 0.243061% and for Vildagliptin was 0.17432% RSD respectively. The result of the percentage recoveries was found to be 98%, 99.5% and 101.6% for Saxagliptin and for Vildagliptin 99.2%, 98.7%, and 99.9%. The effective dissolution method was developed and validated by UV spectrophotometer which is convenient, cost effective, sensitive and rugged for major applications in various pharmaceutical industries.

Keywords: Dissolution; Saxagliptin and Vildagliptin; ICH Guidelines; UV spectrophotometric method.