Article

Liquid Chromatographic Method for the Determination of Metformin and Nateglinide in Pharmaceutical Formulations

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Abstract

A simple and sensitive reverse phase high performance liquid chromatographic method for the determination of metformin and nateglinide was developed on a Shimadzu class vp series HPLC system on a reverse phase Gemini C 18 column (150 mm × 4.6 mm, i.d., 5 μ) using a mobile phase mixture containing methanol and phosphate buffer (pH 3) in the ratio of 60:40. The flow rate was 0.8 mL/min and effluents were monitored at 235 nm and eluted at 2.63 (metformin) and 4.51 min (nateglinide). Calibration curve was plotted with a range from 0.5-50.0 μg/mL for metformin and 0.06-6.00 μg/mL for nateglinide. The assay was validated for the parameters like accuracy, precision, robustness, detection and quantification limits and system suitability parameters. The method was applied for the assay of dosage forms. The results were found to be satisfactory and the method can be adapted for the routine quality control of the drugs in pure and pharmaceutical dosage forms.

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... NTG is included in the official drafts of United States Pharmacopoeia (United States Pharmacopoeia 2011) and European Pharmacopoeia (EDQM 2011) which recommend HPLC method for its assay. In the literature, several HPLC methods (Lakshmi, Rajesh and Shrinivas 2010;Shalini et al. 2010;Kanthi et al. 2008;Li, Tian and Kaic 2008;Varanasi et al. 2008;Danai et al. 2007;Jolly et al. 2007;Pathare, Jadhav andShingare 2006-2007;Srinivas et al. 2007;Wang and Sun 2007;Zhu, Lin and Li 2006;Mao, Liang and Qin 2006;He, Yan and Xiaoyan 2005;Gu 2004;Steffen et al. 2003;Yang, Wang and Liuxi 2002) are available for the determination of NTG in human plasma, rat plasma, rabbit plasma, chiral and related substances. Reported methods for the determination of NTG in pharmaceuticals include HPTLC (Asha et al. 2011;Kale and Kakde 2011), spectrophotometry (Cijo et al. 2011;Sekaran, Lavudu and Prameela 2010;Jain, Bhandari and Purohit 2009;Suresh, Anil and Suresh 2009;Rajasekaran et al. 2004;Sagar, Rao and Sastry 2004;Vidya 2004;Tianbao, Li and Shengli 2003), electrokinetic chromatography (Hongyuan et al. 2004) and capillary electrophoresis (Zhao and Chen 2003). ...
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