ISSN 2063-5346
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Lalit K Sahu, Sudam Si , Saroja Kumar Patro
» doi: 10.31838/ecb/2023.12.si6.465


A novel, simple, robust and stability‐indicating RP-HPLC method has been developed and validated for the simultaneous determination of Vildagliptin and Metformin hydrochloride in the tablet dosage form. The method shows best separation of Vildagliptin and Metformin from their degradation products. Separation was effected on a Sunniest ECO C18, 250 mm x 4.6 mm, 5 mm analytical column at wavelength of 210 nm, using a mobile phase buffer (pH-6.5): acetonitrile (77:23) in an isocratic elution mode at a flow rate of 2.0 ml/min, Injection volume: 10 µl and run time 6mins.All the validation parameters of Analytical Performance like linearity, recovery, and intraday and inter day precision, Limit of Detection (LOD), Limit of Quantitation (LOQ) Robustness and specificity were found to be within acceptance criteria as per ICH guidelines. Retention times under the optimized condition were 2.458 and 4.299 min for Metformin and Vildagliptin, respectively. The results of recovery studies were found to be between 99.0% and 100.38% which indicates the accuracy of the method. The % RSD for inter day and intraday precision studies was found to be less than 1.5%. Robustness and ruggedness were expressed in terms of %RSD which was also within the acceptable limits. The newly developed method was precise, robust and stability indicating as no interfering peaks of degrades and excipients were observed. The proposed method is fast, sensitive and suitable for routine adoption in qualitycontrol laboratories for quantification of both the drugs individually and in combined dosage form and with tremendous precision and accuracy.

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