科研之友
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摘要
A novel liquid chromatographic method has been developed and validated for the determination of ranolazine, its potential four impurities in drug substance and drug products. Efficient chromatographic separation was achieved on a C18 stationary phase (150 x 4.6 mm, 3.0 microns particles) with simple mobile phase combination delivered in gradient mode at a flow rate of 1.0 mL min(-1) at 210 nm. In the developed method, the resolution between ranolazine and its four potential impurities was found to be greater than 2.0. Regression analysis shows an r value (correlation coefficient) greater than 0.999 for ranolazine and for its four impurities. This method was capable to detect all four impurities of ranolazine at a level below 0.004% with respect to test concentration of 1.0 mg mL(-1) for a 10 mu L injection volume. The method has shown good, consistent recoveries for ranolazine (98.8-101.1%) and for its four impurities (97.2-100.3). The test solution was found to be stable in the diluent for 48 h. The drug was subjected to stress conditions. The mass balance was found close to 99.5%.
- 出版日期2009-7
