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Sci. Pharm. 2012, 80(1), 139-152; doi:10.3797/scipharm.1110-13

Simultaneous Determination of Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride in Tablets by a Validated UPLC Method

1
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
2
Center for Pharmaceutical Sciences, IST, J. N. T. University, Kukatpally, Hyderabad-500 072, India
*
Author to whom correspondence should be addressed.
Received: 17 October 2011 / Accepted: 12 December 2011 / Published: 12 December 2011
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Abstract

A novel approach was used to develop and validate a rapid, specific, accurate and precise reverse phase ultra performance liquid chromatographic (UPLC) method for the simultaneous determination of Sitagliptin phosphate mono-hydrate and Metformin hydrochloride in pharmaceutical dosage forms. The chromatographic separation was achieved on Aquity UPLC BEH C8 100 x 2.1 mm, 1.7 μm, column using a buffer consisting of 10 mM potassium dihydro-gen phosphate and 2 mM hexane-1-sulfonic acid sodium salt (pH adjusted to 5.50 with diluted phosphoric acid) and acetonitrile as organic solvent in a gradient program. The flow rate was 0.2 mL min−1 and the detection wavelength was 210 nm. The limit of detection (LOD) for Sitagliptin phosphate monohydrate and Metformin hydrochloride was 0.2 and 0.06 μg mL−1, respectively. The limit of quantification (LOQ) for Sitagliptin phosphate monohydrate and Metformin hydrochloride was 0.7 and 0.2 μg mL−1, respectively. This method was validated with respect to linearity, accuracy, precision, specificity and robustness. The method was also found to be stability-indicating.
Keywords: Sitagliptin phosphate monohydrate; Metformin hydrochloride; UPLC; Simultaneous; Stability-indicating method; Validation; Chromatography Sitagliptin phosphate monohydrate; Metformin hydrochloride; UPLC; Simultaneous; Stability-indicating method; Validation; Chromatography
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

MALLESWARARAO, C.S.N.; SURYANARAYANA, M.V.; MUKKANTI, K. Simultaneous Determination of Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride in Tablets by a Validated UPLC Method. Sci. Pharm. 2012, 80, 139-152.

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