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RP-HPLC Method for the Estimation of Bupivacaine HCl in Pharmaceutical Dosage Forms

Ch. Manohar Babu, V. Jagathi, V. Rajesh, P. Bhaskara Rao, S. M. Basha and G. Devala Rao

A simple and precise RP‐HPLC method was developed and validated for the determination of bupivacaine hydrochloride in pharmaceutical dosage forms. Chromatography was carried out using Waters RP- C18 150 x 4.6 mm, 3.5 μ, pH 6.5 buffer : acetonitrile (50 : 50) as the mobile phase at a flow rate 1.0 mL/min. The analyte was monitored using PDA detector at 220 nm. The retention time of the drug was 5.46 min for bupivacaine hydrochloride. The proposed method was found to have linearity in the concentration range of 25 – 150 μg/mL with correlation coefficient of r2 = 0.9999. The developed method has been statistically validated and found simple and accurate. The mean recoveries obtained for bupivacaine hydrochloride were in the range 100.06‐101.9%. Due to its simplicity, rapidness, high precision and accuracy of the proposed method, it may be used for determining bupivacaine hydrochloride in bulk and dosage forms.