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Development of RP-HPLC Method for Estimation of Drotaverine Hydrochloride in Pharmaceutical Formulations

Author(s): B. S. Sastry, S. Gananadhamu and G. Devala Rao

drotaverine hydrochloride is a novel antispasmodic agent. A simple, selective and precise RPHPLC method was developed for quantification of Drotaverine hydrochloride in pharmaceutical formulations. The sample was analyzed on reverse phase C18 column (250 mm length, 4.6 mm internal diameter and 5 8m particle size) by using a fixed composition of mobile phase consisting of 25 millimolar sodium acetate buffer (pH was adjusted to 4.50 with acetic acid after addition of 2 mL of triethyl amine) and acetonitrile in the ratio of 55 : 45 v/v. The mobile phase was passed through the system at a flow rate of 1.0 mL/min and the analyte was monitored with UV detector at 354 nm. The proposed method is having a run time of 12 min with analyte retention time around 7.42 min. The developed method shows linearity in the concentration range of 4-12 8g/mL. The method was validated for use in routine quality control of drotaverine hydrochloride in pharmaceutical formulations.

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