Simultaneous HPLC determination of nitrendipine and impurities of the process of synthesis
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A method has been developed for separation of nitrendipine and its impurities of reaction partners and side reaction products by high-performance liquid chromatographic method on a RP-ls column and detection at 238 nm. The mobile phase composition that provided an acceptable nitrendipine resolution, in large excess and possible impurities, in a short elution time, is methanol:water (70:30) and pH 3. Linearity (r greater than or equal to 0.999), reproducibility (RSD = 0.8-1.4%), determination limit (0.5 2%,) and recovery (99.8-102.3) were validated and found to be satisfactory. This method enables monitoring of the process of synthesis, as well as the choice of the synthetic design.
Izvor:Journal of Pharmaceutical and Biomedical Analysis, 2001, 24, 5-6, 993-998
- Pergamon-Elsevier Science Ltd, Oxford