Method Development, Validation and Forced Degradation Studies of Voglibose and Metformin in Pure and Pharmaceutical Dosage Form by RP-HPLC

Author(s): B. Mamatha*, V. Narmada and R. Shyamsunder

Abstract: Objective: The objective of the present research work was to develop an innovative, simple, and economic method for estimation of Voglibose and Metformin in bulk and dosage form by RP-HPLC. Methods: The chromatographic conditions were performed on Waters ODS (C18) RP Column, 250 mm x 4.6 mm. 5μm i.d.as stationary phase and mobile phase was prepared with a mixture of Phosphate Buffer (pH- 6.5): Acetonitrile = (65: 35) flow 1.0 ml/min, with Injection Volume 10μl, at detection wavelength 251 nm and run time at 6.0 mins. Results: The analytical method is valid for estimation of Voglibose and Metformin over a range of 10 μg/ml–60 μg/ml and 05 μg/ml–40 μg/ml. The results of system suitability test, linearity, precision and accuracy, robustness, specificity, LOD and LOQ and stabilities presented in this report are within the acceptance range. Conclusion: A specific, sensitive, economic method estimation of Voglibose and Metformin has been developed based on ICH Guidelines with bulk and dosage forms.

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