A Novel Stability Indicating Analytical Development and Validation of an RP-HPLC Assay Method for the Quantification of Voglibose in Bulk and its Formulation

The investigation developed a new stability-indicating Reverse phase high-pressure liquid chromatographic (RP-HPLC) assay method to quantify Voglibose in bulk and pharmaceutical dosage form. The technique used isocratic elution on an Amino (NH2) column (250x4.6mm, 5µ particle size) with a mobile phase of Phosphate Buffer (pH 6.7) and Acetonitrile (27:73 v/v). The separation was monitored using UV detection at 210 nm. The method was validated, meeting ICH guidelines. The retention time of Voglibose was 6.38 minutes, and the linearity was between 24-56 µg/ml. The limit of detection and quantitation were 0.70 and 2.11 µg/ml, respectively. Analytical performance parameters were determined according to ICH guidelines. The method was simple, precise, accurate, robust, and rapid, making it suitable for quantifying Voglibose in bulk and tablet formulation.