Original Articles
Santosh Kumar Bhardwaj*1,2, Da
Abstract
The paper reports recent efforts to develop and validate an efficient and rapid fast LC method for determination of azithromycin and its related compounds in its dosage form. The aim of the study is to develop a simple, accurate, precise, sensitive, less expensive and less time consuming RP-HPLC method by using small column with less particle size in pharmaceutical dosage form. The separation was achieved by using a Shim pack XR ODS, 75×3.0mm, 2.2 μm column with a mobile phase -A consisting 0.01 M dibasic sodium phosphate buffer and mobile phase -B consisting 750:250 (v/v) of acetonitrile and methanol .Detection was carried out at 210 nm and the flow rate was1.2 ml/minute. The method was capable of resolving two of the known and three unknown process related impurities. The method was validated for parameters like, specificity, accuracy, linearity, precision, specificity, robustness and system suitability. The column efficiency as determined is not less than 2000 USP plate count and the tailing factor is not more than 2.0. The % relative standard deviation for the peak areas of the six replicate injections is not more than 2.0%. The recovery results indicating that the test method has an acceptable level of accuracy. The correlation coefficient met the acceptance criteria of NLT 0.999. The LOD and LOQ values from the study demonstrate that the method is sensitive. The system suitability parameters found to be within the limits. The method was found to be accurate, precise, linear, specific, sensitive, rugged, robust, and stability-indicating.