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Validation and Determination of Macrolide Antibiotic Clarithromycin Tablets By HPLC Method as Per ICH Guidelines Q2 (R1)

Rajesh Kumar Nayak*, Dillip Kumar Mohapatra, Manjit Singh

Our aim of study is to develop an efficient least time consuming and simple and sensitive method for the determination of clarithromycin tablets USP 250 mg and Clarithromycin tablets USP 500 mg are dose weight proportionate. The chromatographic analysis was performed in an isocratic separation mode by a Capcell Pak C18 column (150 mm × 4.6 mmi.d, 5 μm particle size). The mobile phase was a homogenous mixture of acetonitrile and potassium dihydrogen phosphate (0.035 M) in the ratio of (55: 45, v/v) at pH 4.4 ± 0.017, pumped at a flow rate of 0.6 ml/min and the effluent was monitored at wavelength 210 nm. The injection volume was 20 μl and the run time was about 6 min as the retention time of clarithromycin was found about 4.1 min. Hence entire validation shall be carried out on highest strength i.e. 500 mg. The developed method was validated as per ICH guidelines and its updated international convention. The linearity of response, precision, ruggedness and robustness of the described method has been checked. The system suitability parameters met the acceptance criteria, which were commenced during study of each individual validation characteristics.