Development and validation of novel stability-indicating high-performance liquid chromatography method for the determination of miglitol in pharmaceuticals

Abstract

A reversed phase high performance liquid chromatographic (RP-HPLC) method for the determination of miglitol (MGL) in pharmaceuticals is presented. The assay was performed on a Phenomenex Luna C₁₈ (150 × 4.6 mm; 5µm particle size) column using phosphate buffer (pH 3.7)-methanol (40:60 v/v) as mobile phase at a flow rate of 1 ml min^-1 and uv detection at 270 nm. The column temperature was maintained at 30 ᴼ C and the retention time of the analyte was 5.58 min. Mean peak area versus concentration plot was found to be linear over 1-750 µg ml^-1 (r = 0.9999), and the calculated limits of detection (LOD) and quantification (LOQ) were 0.05 and 0.15 µg ml^-1, respectively. Intra-day and inter-day precisions, expressed as %RSD, were ≤0.07% and ≤0.69%, respectively; and the corresponding accuracies, expressed as %RE, were better than 1%. Robustness and ruggedness of the method were checked. The method was also validated for selectivity by placebo blank and synthetic mixture analyses. The method was applied to determine active ingredient in tablets and results agreed well. The results of stress studies showed that the drug was prone to slight degradation under acid- and oxidant- induced stress conditions, but inert to other conditions.