Development and Validation of Stability Indicating UV Spectrophotometric Method for the Estimation of Sitagliptin Phosphate in Bulk and Tablet Dosage Form

Pathade, Parag; Imran, Md; Bairagi, Vinod; Ahire2, Yogesh
March 2011
Journal of Pharmacy Research;Mar2011, Vol. 4 Issue 3, p871
Academic Journal
A simple, sensitive, reproducible and cost effective stability indicating UV Spectrophotometric method has been developed for quantitative determination of Sitagliptin Phosphate in bulk and pharmaceutical formulations. The UV spectrum was scanned between 200 to 400 nm and 267 nm was selected as maximum wavelength for absorption. Beer's law was obeyed in the concentration range of 10-100 mg/ml. Good accuracy (99.87-100.45%), precision (%RSD 1.3147-1.2957) were found, the method was successfully applied to the pharmaceutical dosage form containing the above-mentioned drug without any interference by the excipients. The limit of detection and limit of quantification was found to be 0.16 μg/ml & 0.45 μg/ml respectively. Results of the analysis were validated as per ICH guidelines. Forced degradation studies includes the effect of temperature, oxidation, photolysis and susceptibility to hydrolysis across a wide range of pH values, were carried out according to the ICH requirements which can be used for the routine and quality control analysis of Sitagliptin Phosphate in raw material and pharmaceutical formulations.

Tags: TABLETS (Medicine);  EXCIPIENTS;  DRUG stability;  DRUGS -- Dosage forms;  COST effectiveness


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