RP-HPLC Method Development and Validation for the Determination of Bupropion Hydrochloride in a Solid Dosage Form.

A simple, rapid, precise, sensitive, cost effective and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the determination of bupropion HCl in a solid dosage form. The proposed RP-HPLC method was developed on phenomenex LunaR (C-18 250 × 4.6 mm, 5μm) column with a mobile phase composed of methanol : acetate buffer (pH-6) in the ratio of 80:20 in isocratic mode at a flow rate 1.0 mL/min. Detection was carried out using UV detector at 251 nm. The retention time under optimized chromatographic conditions was found to be 3.19 minutes. A good linear response was observed in range of 15-90 μg/mL. The interday and interaday precision was found to be within limits. The proposed method has adequate sensitivity, reproducibility and specificity for determination of bupropion HCl in solid dosage form. LOD (Limit of detection) and LOQ (Limit of quantitation) for bupropion HCl were found to be 5 μg/mL and 15 μg/mL.