Main Component Self-compare with Calibration Factor Method for Determination of Related Substances in Perindopril Tablets

OBJECTIVE To estabilish the main component self-compare with calibration factor method for determination of related substances in perindopril tablets. METHODS The GL Inertsil C8-3 column (4.0 mm×150 mm, 5 μm) was adopted with the mobile phase composed of water (adjusted to pH 2.5 with 50% perchloric acid) and acetonitrile solution(contain with 0.03% perchloric acid), pumped at a flow rate of 1.0 mL·min^-1, the detection was carried out at 215 nm and the column temperature was 60℃, the injection volume was 20 μL. The slope of linear equation was used to determine the correction factor between impurity B, E, F and perindopril. The relative retention on time was used to determine the position of impurities. The developed method was validated. The results obtained by the proposed method were compared with those by using the reference standards of impurities to verify the method accuracy. RESULTS The relative retention time of imputiry B, E, F was 0.68, 1.14, 1.61, respectively. The correction factor of imputiry B, E, F was 0.77, 1.02, 1.24, respectively. The limits of detection and quantification of imputiry B, E, F were found to be 2.24, 0.52, 1.02 ng and 6.73, 1.57, 3.06 ng, respectively. There were no significant diferences in the results determined by the external and by the self-compare with calibration factor method. CONCLUSION The method is simple, efficient and accurate for analyzing the related substances B, E and F in perindopril tablets.