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Ramisetti Nageswara Rao Dhananjay D. Shinde Venna Ramesh Ragampeta Srinivas 《Journal of separation science》2009,32(9):1312-1322
Modafinil, adrafinil and their related substances were synthesized and analyzed by RP‐LC with ESI‐MS/MS. The ionization mode, polarity, cone voltage, and chromatographic conditions were evaluated. The optimum LC‐MS conditions to obtain fragment ions indispensable for identification of the structures were described. The bulk drugs purity of modafinil and adrafinil was evaluated on Kromasil C18 column with ACN/0.02 M ammonium acetate as mobile phase in gradient elution mode at 30°C. The method was found to be suitable not only for monitoring the reactions during the process development but also for quality assurance of modafinil and adrafinil. 相似文献
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A reversed-phase high-performance liquid chromatographic (RP-HPLC) method for determination and evaluation of purity of modafinil in bulk drugs using Kromasil C18 column with acetonitrile: 0.02 M ammonium acetate as a mobile phase in gradient elution mode at 30 °C and detection at 225 nm using photodiode array detector has been developed. The effects of pH, temperature and the percent of organic modifier on resolution were studied. Related substances, viz, sulphide, sulphoxide, sulphones of the modafinil, acid and ester derivatives, were separated and quantified. The method was found to be simple, rapid, selective and capable of detecting all process related impurities at trace levels in the finished products of modafinil with detection limits of 0.6-2.4 × 10−8 g. The method was validated with respect to accuracy, precision, linearity, ruggedness, and limits of detection and quantification. It was found to be suitable not only for monitoring the reactions during the process development but also quality assurance of modafinil. 相似文献
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