Development and Validation of a Reversed-Phase HPLC Method for the Analysis of Ornidazole in Pharmaceutical Dosage Forms

Abstract

The present study describes the estimation of ornidazole in pharmaceutical
dosage forms. Ornidazole was chromatographed on a
reverse phase C- 18 column using mebendazole as an internal
standard in a mobile phase consisting of acetonitrile and water
(consisting of triethylamine and adjusted to pH 3.6 with 5% orthophosphoric
acid) in the ratio of 38 : 62 v/v respectively. The mobile
phase was pumped at a flow rate of 0.8 mL/min and the eluents
were monitored at 254 nm. The method was statistically validated
for its linearity, precision and accuracy. The calibration curve was
linear in the range of 0.1 to 40  μg/mL. The intra- and inter-day
variation was found to be less than 1 % indicating high precision of
the assay method. The mean recovery of the drug from the solutions
containing 5, 10 or 20  μg/mL was 98.47 ± 0.37% indicating high
accuracy of the proposed HPLC method. It does not require any
specific sample preparation except the use of a guard column before
the analytical column and a suitable pre-filter attached to the syringe
prior to injection. Due to its simplicity, rapidness, high precision
and accuracy, the proposed HPLC method may be used for the
estimation of ornidazole in bulk drug samples or in pharmaceutical
dosage forms.