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

MALLESWARARAO, Chellu S. N.; SURYANARAYANA, Mulukutla V.; MUKKANTI, Khagga

doi:10.3797/scipharm.1110-13

Open AccessArticle

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

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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

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

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