Development and Validation of New RP-HPLC Method For The Estimation of Voglibose In Bulk And Pharmaceutical Dosage Form
Keywords:
Voglibose; RP-HPLC; Method Development; ICH; Validation; Tablet dosage formAbstract
Background: Voglibose is used to lower blood glucose level in patients with Type 2 Diabetes Mellitus, especially when other medicines are not able to provide the desired results.
Aim and Objective: To develop and validate a simple, rapid, accurate and precise RP-HPLC method validated for the determination of Voglibose in table dosage form.
Materials and Method: Chromatographic analysis of the drug was achieved on C18 column (250 mm x 4.6 mm, 5 μm) as stationary phase with mobile phase consisting of acetonitrile and water in the ratio of 70: 30 v/v.
Results: The method showed a good linear response in the concentration range of 10-60 μg/ml with correlation coefficient of 0.999. The flow rate was maintained at 1.0 ml/min and detection was carried out at 214.5 nm. The retention time was 3.08 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines.
Conclusion: The method was found to be simple, sensitive and economical used for the determination of Voglibose in tablet formulation.
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