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Stability-Indicating RP-HPLC Method for Simultaneous Determination of Metformin Hydrochloride and Sitagliptin Phosphate in Dosage Forms

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Abstract

A new stability-indicating high-performance liquid chromatographic method has been developed for simultaneous analysis of metformin hydrochloride (MET) and sitagliptin phosphate (SIT) in pharmaceutical dosage forms. Chromatographic separation was achieved on a C8 column. The mobile phase was methanol–water 45:55 % (v/v) containing 0.2 % (w/v) n-heptanesulfonic acid and 0.2 % (v/v) triethylamine; the pH was adjusted to 3.0 with orthophosphoric acid. The flow rate was 1 mL min−1 and the photodiode-array detection wavelength was 267 nm. The linear regression coefficients for metformin and sitagliptin were 0.9998 and 0.9996 in the concentration ranges 50–450, and 10–150 μg mL−1, respectively. The relative standard deviations for intra and inter-day precision were below 1.5 %. The drugs were subjected to a variety of stress conditions—acidic and basic hydrolysis, and oxidative, photolytic, neutral, and thermal degradation. The products obtained from photolytic degradation were similar to those from neutral hydrolytic degradation and different from produced by acidic and basic hydrolysis. The method resulted in detection of 15 degradation products (D1–D15); among these, the structures of D1, D3, D9, and D13 were identified. The respective mass balance for MET and SIT was found to be close to 97.60 and 99.12 %. The specificity of the method is suitable for a stability-indicating assay.

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Acknowledgments

The authors wish to thank the Hetero Laboratories Pvt. Ltd, Analytical Research Laboratory, JSS University, Nilgiris DT, TN, and the Indian Institute of Chemical Technology, Hyderabad, India, for supporting this work.

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Authors and Affiliations

  1. Division of Pharmaceutical Analysis and Quality Assurance, Raghavendra Institute of Pharmaceutical Education and Research, Anantapur, 515 721, Andra Pradesh, India

    Ramalingam Peraman, Chandra Sekhar Gowra, Y. Padmanabha Reddy & Krishna Karthik Peruru

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  1. Ramalingam Peraman
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  2. Chandra Sekhar Gowra
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  3. Y. Padmanabha Reddy
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  4. Krishna Karthik Peruru
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Correspondence to Chandra Sekhar Gowra.

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Peraman, R., Gowra, C.S., Reddy, Y.P. et al. Stability-Indicating RP-HPLC Method for Simultaneous Determination of Metformin Hydrochloride and Sitagliptin Phosphate in Dosage Forms. Chromatographia 76, 1153–1162 (2013). https://doi.org/10.1007/s10337-013-2525-4

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  • DOI: https://doi.org/10.1007/s10337-013-2525-4

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