Method Development and Validation of Voglibose in pure and Pharmaceutical Dosage form by RP-HPLC

Jogu Anitha*, P. Sunitha, Vijaya Kuchana
Department of Pharmaceutical Analysis, Teegala Krishna Reddy College of Pharmacy, Meerpet, Hyderbad.

A B S T R A C T
The chromatographic conditions were successfully developed for the separation of Voglibose by Deveosil ODS-HG-5 C₁₈ (250×4.6mm, 5cm) column. Flow rate was 1ml/min, mobile phase ratio was 70:30% v/v Acetonitrile : Buffer, UV detection at 242nm. The instrument used was Waters HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 2.29 mins. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Voglibose was found in concentration range of 0µg-28µg and correlation coefficient (r²) was found to be 0.999, % recovery was found to be 103.29%, %RSD for repeatability was 0.795, % RSD for intermediate precision was 1.0. The precision study was precision, robustness and repeatability. LOD value was 0.452 and LOQ value was 1.356.Hence the suggested RP-HPLC method can be used for routine analysis of Vogibose in API and Pharmaceutical dosage form. Further, a flow rate of 0.5ml/min & an injection volume of 20 µl were found to be the best analysis. The result shows the developed method is yet another suitable method for assay and stability studies which can help in the analysis of Voglibose in different formulations. A sensitive & selective RP-HPLC method has been developed & validated for the analysis of Voglibose API. Further the proposed RP-HPLC method has excellent sensitivity, precision and reproducibility.
Keywords: Voglibose, RP-HPLC method, sensitivity, precision and reproducibility