Li, Q. Chan published the artcileValidation of a high-performance liquid chromatography method for the assay of and determination of related organic impurities in nevirapine drug substance, Application In Synthesis of 133627-45-9, the main research area is HPLC impurity determination nevirapine; liquid chromatog nevirapine impurity determination.
Nevirapine (Viramune), a dipyridiodiazepinone, is a potent and highly specific nonnucleoside inhibitor of HIV-1 reverse transcriptase. This study described the validation of a specific, sensitive, and a stability-indicating HPLC method for the determination of related organic impurities in nevirapine drug substance. This method used a Supelcosil LC-ABZ column, a mobile phase of 20:80 MeCN-pH 5.0 25-mM NH4H2PO4 and UV detection at 220 nm. This method was validated for specificity, linearity, accuracy, repeatability, detection limit, quantitation limit, stability of analyte solutions, robustness, and intermediate precision. Nevirapine was completely separated from all impurities. The method was linear with coefficients of determination >0.999. Average accuracy was 100.4% with a relative standard deviation of 0.7% for the assay. Accuracy ranges from 100.1 to 102.6% for related organic impurities. The repeatability was good, with relative standard deviations â?.4%. The detection limit and the quantitation limit were 0.001 and 0.003%, resp. Relative response factors of known organic impurities were determined, permitting the use of nevirapine at the 0.1% level as an external standard for the quantitation of these impurities. Analyte solutions were stable for at least 2 days at ambient temperature The method was validated as robust, and intermediate precision was high. A system suitability test was developed and validated, and requirements were set. (c) 2000 Preston Publications.
Journal of Chromatographic Science published new progress about HPLC. 133627-45-9 belongs to class pyridine-derivatives, name is 2-Chloro-4-methylpyridin-3-amine, and the molecular formula is C6H7ClN2, Application In Synthesis of 133627-45-9.