Zeitschrift für Chromatographie und Trenntechniken
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Abstrakt

Development and Validation of RP-UPLC Method for Determination of Related Substances in Risperdal^® Consta^®

Cheng-Tung Chen, Cheng-Wei Cheng and Yu-Fang Hu

In this work, a validated stability-indicating ultra-high performance liquid chromatographic (UPLC) method has been developed for quantitative determination of related substances in RisperdalⓇ ConstaⓇ. The chromatographic separation was achieved on a Waters BEH C18 column (2.1 × 100 mm, 1.7 μm) in an isocratic elution mode. The limit of quantification is 0.1 μg/mL, and the method is linear over the concentration range of 0.1-1.5 μg/mL for risperidone. The PLGA polymers have been dissolved in organic phase (acetonitrile) and precipitated in aqueous phase (0.01 N HCl). This simple step avoids the clogging of column and makes the method more robust. The mean recovery of extracted risperidone from PLGA microspheres is 99.26 ± 1.22%. Herein, this method was proved to be highly reliable and applicable for measuring impurities in PLGA microspheres.