Journal: Journal of Pharmacy Research
Title: Development and Validation of Stability Indicating UV Spectrophotometric Method for the Estimation of Sitagliptin Phosphate in Bulk and Tablet Dosage Form
Category: Pharmaceutical Analysis
Section: Research Article
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Abstract
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 ìg/ml & 0.45 ìg/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.
Cite this article as: Parag Pathade , Md Imran ,Vinod Bairagi , Yogesh Ahire,Development and Validation of Stability Indicating UV Spectrophotometric Method for the Estimation of Sitagliptin Phosphate in Bulk and Tablet Dosage Form,Journal of Pharmacy Research 2011,4(3),871-873.
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About the authors and Affiliations
Author(s) Name: Parag Pathade*1, Md Imran1, Vinod Bairagi 2 and Yogesh Ahire2
Affiliation(s) Name: *1Department of pharmaceutical analysis, KBHSSTs Institute of Pharmacy, Malegaon Dist Nasik Maharashtra India.
2Department of pharmacology,K.B.H.S.S.T’s institute of pharmacy, Malegaon-camp, Malegaon, Dist- Nasik, Maharashtra,India.*Corresponding author.
P. A. Pathade
Department of pharmaceutical analysis,
K.B.H.S.S.T’s institute of pharmacy,
Malegaon-camp, Malegaon,
Dist- Nasik, Maharashtra, India
Received on: 05-10-2010; Revised on: 14-12-2010; Accepted on:09-02-2011-
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Author: Parag Pathade*1, Md Imran1, Vinod Bairagi 2 and Yogesh Ahire2
Title: Development and Validation of Stability Indicating UV Spectrophotometric Method for the Estimation of Sitagliptin Phosphate in Bulk and Tablet Dosage Form Journal: Journal of Pharmacy Research Vol(issue): 4 (March) Year: 2011 Page No: (871-873) -
Experimental Methods Keywords
Methodology: Spectrometry, Stability Indicating, Validation. Research Materials: Sitagliptin Phosphate
Keywords
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