Development and validation of rp-hplc method for quantitation of clarithromycin in matrix tablet dosage form

Abstract

This study was aimed to develop a simple, sensitive and rapid procedure for the analysis of
clarithromycin in pure as well as in matrix tablet dosage form by using RP-HPLC method. The chromatographic
separation was achieved by a reversed phase C18 column (150 mm length × 4.6 mm i.d., 5 μm particle size) in an
isocratic mode with mobile phase comprising of acetonitrile and 0.035 M potassium dihydrogen phosphate (pH 4.4 ±
0.017) in a ratio of (55: 45, v/v). The eluent was pumped at a flow rate of 0.6 ml/min and the effluent was monitored
using UV detector at 210 nm. The method was validated according to the ICH guidelines with respect to linearity,
precision, accuracy, selectivity, specificity, ruggedness and robustness. It was found to be linear over the
concentration range of 320- 480 μg/ml (R2= 0.9993) with detection limit of 0.04 μg/mL. Considering the
specifications of this method, the system was found to be suitable for rapid and routine analysis of clarithromycin in
pure and matrix tablet dosage form.