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Asian Journal of Research in Chemistry
Year : 2015, Volume : 8, Issue : 7
First page : ( 472) Last page : ( 480)
Print ISSN : 0974-4169. Online ISSN : 0974-4150.
Article DOI : 10.5958/0974-4150.2015.00076.0

Quantitative planner chromatographic method development for sitagliptin phosphate monohydrate and metformin hydrochloride in presence of their degradation product

Walode Sanjay G.1,*, Kasture Avinash V.2

1Department of Pharmaceutical Chemistry, Sinhgad Institute of Pharmaceutical Sciences, Kusgaon (Bk), Lonavala, Pune, 410 401, India

2Department of Pharmaceutical Chemistry, University Department of Pharmaceutical Sciences, Nagpur-440 010, India

*Corresponding Author E-mail: sanjuwalode@rediffmail.com, sgwalode.sips@sinhgad.edu

Online published on 17 October, 2015.

Abstract

This paper presents the stability indicating method for the simultaneous analysis of sitagliptin phosphate monohydrate and metformin hydrochloride using High Performance Thin Layer Chromatography (HPTLC) with densitometric detection. Separation of both the drugs was performed on silica gel G 60F254 plates with detection wavelength of 216 nm. The mobile phase is comprised of acetonitrile-methanol-glacial acetic acid (7.0: 3.0: 0.02 v/v/v). The Rf values were found to be 0.21 ± 0.035 and 0.53 ± 0.029 for sitagliptin phosphate monohydrate and metformin hydrochloride, respectively. The linear regression analysis data for the calibration plots showed good linear relationship with respect to peak area in the concentration range 8–64 ng/band of sitagliptin (with r= 0.9992) and 80–640 ng/band of metformin (with r= 0.9994). The method was validated as per International Conference on Harmonization guideline (ICH) for accuracy, precision, robustness, and specificity, limit of detection and limit of quantitation. Statistical analysis of results obtained proves that the method is repeatable and selective for estimation of both the drugs. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method.

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Keywords

Sitagliptin phosphate monohydrate, Metformin hydrochloride, HPTLC, Validation, Stability indicating method, Degradation.

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