Development and Validation of a Stability-Indicating HPLC Method for the Determination of Acarbose in Pharmaceutical Dosage Forms

Abstract

The United States Pharmacopeia 39 uses an HPLC–UV method for the assay of acarbose and its impurities in bulk form. However, there is no information about the stability-indicating nature of the proposed method for the assay of acarbose in tablets. Therefore, in this study, stress tests were firstly applied on the bulk and drug product based on International Conference on Harmonization. Then, verification and revalidation of the proposed method were performed using stressed and untreated samples. Separation was achieved on a Lichrospher^®‒100–NH₂, 5 µm, 250 × 4.6 mm i.d. column using a mobile phase consisting of acetonitrile–0.007 M phosphate buffer (pH 6.7) (750 : 250, v/v) at a flow rate of 2 mL/min and UV detection at 210 nm. The column was maintained at 35°C and an injection volume of 10 µL was used. The linearity of the developed method was investigated in the range of 2.5–20 mg/mL (R² = 0.9995). Peak purity results using a diode array detector have shown that degradation products did not interfere with the detection of acarbose and the assay can thus be considered stability-indicating.