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Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin and Sitagliptin in Bulk and Tablet Dosage Forms

Gandla Kumara Swamy , Gandla Kumara Swamy1 , Bathula Annu2 , Repudi Lalitha3 , M Lakshi Surekha4

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Journal of Pharmaceutical and Medicinal Chemistry 5(2):p 75-79, July-December 2019. | DOI: DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.5219.2

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Gandla Kumara Swamy, Bathula Annu, Repudi Lalitha et al. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin and Sitagliptin in Bulk and Tablet Dosage Forms. J Pharmaceut Med Chem. 2019;5(2):75-79.

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Abstract

The current research work is validated RP-HPLC method developed and validated for simultaneous determination of Metformin and Sitagliptin in pure and combined tablet dosage forms. Sulfonylureas is used as an internal standard drug and current research method an accurate, precise and reproducible high performance liquid chromatographic method was developed for quantitative estimation of Metformin and Sitagliptin simultaneously in tablet dosage forms. Shimadz SPD 10A (S.K.) gradient System UV Detector and C 18 (Primesil) column with 250 mm x 4.6 mm i.d. and 5μm particle size. Distilled water: Methanol 0.05% Ortho phosphoric acid (50:50) composition of solvent system used as the mobile phase for the method. The detection wavelength was 245 nm and flow rate was 1.2 ml/min. In the developed method, the retention time of Metformin and Sitagliptin were found to be 2.1 min and 7.6 min. The proposed research method was validated according to the ICH guidelines. The range, calibration curve, accuracy and precision, robustness was within the limits as specified by the ICH guidelines. So the proposed methods can be used for the routine quality control analysis of Metformin and Sitagliptin simultaneously in tablet dosage forms.

Keywords: RP-HPLC: Metformin and Sitagliptin; Sulfonylureas internal standard drug; Method development and validation; Tablet dosage forms.

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Gandla Kumara Swamy, Bathula Annu, Repudi Lalitha et al. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin and Sitagliptin in Bulk and Tablet Dosage Forms. J Pharmaceut Med Chem. 2019;5(2):75-79.

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DOI: DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.5219.2

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