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Sci. Pharm.
Volume 80
Issue 1
10.3797/scipharm.1110-13
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Scientia Pharmaceutica is published by MDPI from Volume 84 Issue 3 (2016). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Austrian Pharmaceutical Society (Österreichische Pharmazeutische Gesellschaft, ÖPhG).
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Article

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

by
Chellu S. N. MALLESWARARAO
1,2,*,
Mulukutla V. SURYANARAYANA
1 and
Khagga MUKKANTI
2
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.
Sci. Pharm. 2012, 80(1), 139-152; https://doi.org/10.3797/scipharm.1110-13
Submission received: 17 October 2011 / Accepted: 12 December 2011 / Published: 12 December 2011
Versions Notes

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 ?m, 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 ?g mL?1, respectively. The limit of quantification (LOQ) for Sitagliptin phosphate monohydrate and Metformin hydrochloride was 0.7 and 0.2 ?g 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

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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. https://doi.org/10.3797/scipharm.1110-13

AMA Style

MALLESWARARAO CSN, SURYANARAYANA MV, MUKKANTI K. Simultaneous Determination of Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride in Tablets by a Validated UPLC Method. Scientia Pharmaceutica. 2012; 80(1):139-152. https://doi.org/10.3797/scipharm.1110-13

Chicago/Turabian Style

MALLESWARARAO, Chellu S. N., Mulukutla V. SURYANARAYANA, and Khagga MUKKANTI. 2012. "Simultaneous Determination of Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride in Tablets by a Validated UPLC Method" Scientia Pharmaceutica 80, no. 1: 139-152. https://doi.org/10.3797/scipharm.1110-13

APA Style

MALLESWARARAO, C. S. N., SURYANARAYANA, M. V., & MUKKANTI, K. (2012). Simultaneous Determination of Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride in Tablets by a Validated UPLC Method. Scientia Pharmaceutica, 80(1), 139-152. https://doi.org/10.3797/scipharm.1110-13

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