DEVELOPMENT OF A NOVE STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND TENELIGLIPTIN HYDROBROMIDE AND IN BULK AND COMBINED TABLET DOSAGE FORMS

Gandla Kumaraswamy, M Parashuram, K Pranay, D Sudheer kumar

Abstract


The present method validated RP-HPLC method developed and validated for simultaneous estimation of Metformin and teneligliptin in bulk and Tablet dosage forms. An accurate, precise and reproducible high performance liquid chromatographic method was developed for quantitative estimation of Metformin and teneligliptin simultaneously in tablet dosage forms. Shimadz SPD 10A  (S.K.) gradient System UV Detector and C18 (Primesil) column with 250mm x4.6 mm i.d. and 5μm particle size. Methanol: water 0.05 % OPA (50:50) was used as the mobile phase for the method. The detection wavelength was 241 nm and flow rate was 1.0 ml/min. In the developed method, the retention time of Metformin and Teneligliptin were found to be 2.1 min and 7.6 min. The developed method was validated according to the ICH guidelines. The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible. So the proposed methods can be used for the routine quality control analysis of Metformin and Teneligliptin simultaneously in tablet dosage forms.


Keywords


RP-HPLC.; Metformin and Teneligliptin, method development and validation; Tablet dosage forms.

Full Text:

39-42

References


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DOI: http://dx.doi.org/10.24018/10.24018/iijmps.2018.v1i1.22

DOI (39-42): http://dx.doi.org/10.24018/10.24018/iijmps.2018.v1i1.22

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