Analytical Method Development And Validation Parameters Of Drug Ivermectin

Pharmaceutical Science-Allied Sciences

Abstract

An accurate, easy, detailed, selective and fast RP-HPLC stability representative technique was developed and validated for assessment of ivermectin in tablet dosage form. The Reverse Phase High Performance Liquid Chromatographic technique was developed for routine quantification of ivermectin in laboratory prepared mixtures as well as in combined dosage forms. The chromatographic separation was accomplished with INERTSIL C-18 ODS 250×4.6mm, 5µm particle size column along with acetonitrile and methanol as the mobile phase at a flow rate of 1ml/min. Quantification was completed by using a UV detector at 245 nm and the run time was 10 minutes. The retention time was found to be 4.198 min for ivermectin. The linearity was observed in the range of 1-32µg/ml with correlation coefficient r= 0.9798. The % RSD for intraday and interday precision was 1.352 and 1.589 respectively. The LOD and LOQ values were found to be 2.93 and 8.79, respectively. The system suitability parameters for ivermectin such as theoretical plates and tailing factor were found to be 129.949 and 2.0, respectively. Robustness was also studied and there was no significant variation in the system suitability of the analytical method by incorporating small changes in experimental parameters. The technique has been validated for linearity, precision, accuracy and other parameters as approved by ICH guidelines. The results obtained by RP- HPLC methods are found to be fast, detailed, selective and accurate. Therefore, proposed analytical method can be used for regular analysis of ivermectin in injection, tablet and other formulations.