Abstract

RP-UPLC DEVELOPMENT AND VALIDATION OF METFORMIN HYDROCHLORIDE IN PURE DRUG AND PHARMACEUTICAL FORMULATIONS

Cijo M Xavier, Kanakapura Basavaiah*,

ABSTRACT

A stability-indicating, robust, fast, and user friendly reversed-phase ultra-performance liquid chromatographic (UPLC) assay method has been developed and validated for the analysis of metfotmin hydrochloride (MFH). The drug was degraded under different stress test conditions prescribed by International Conference on Harmonization (ICH). The drug was well separated from degradation products using a reversed-phase (C-18) column (Waters Acquity BEH C18, 100 mm × 2.1 mm, 1.7 μm) and a mobile phase comprising of equal volumes of methanol and acetonitrile mixture (30%) and phosphate buffer with pH 3.2 (70%), which was delivered initially for 5 min. Other UPLC parameters were: flow rate, 0.20 mL min-1; detection wavelength, 230 nm; and injection volume, 2 μL. The method was validated for linearity, precision, accuracy, specificity and selectivity. The linear regression analysis for the calibration curve showed a good linear correlation over the concentration range, 0.1–300 μg mL-1, with regression coefficient, r of 0.9999. The limit of detection (LOQ) and limit of detection (LOD) were 0.01 and 0.002 μg mL-1 respectively. The accuracy of the method was further ascertained by recovery studies via standard addition procedure and the recoveries obtained were 100.7 – 101.4%. Forced degradation of the bulk sample was conducted in accordance with the ICH guidelines. Fair recovery was obtained when the drug was spiked with its tablets.

Keywords: Metformin, UPLC, Stability indicating, Validation.