Sci. Pharm. 2012; 80: 139–152
Simultaneous Determination of Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride in Tablets by a Validated UPLC Method
Chellu S. N. MALLESWARARAO * 1,2, Mulukutla V. SURYANARAYANA 1, 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.
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.
Sitagliptin phosphate monohydrate • Metformin hydrochloride • UPLC • Simultaneous • Stability-indicating method • Validation • Chromatography
Received October 17th, 2011 | Accepted December 12th, 2011 | Published Online December 12th, 2011