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[문헌]Solifenacin Succinate
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인쇄
스크랩
솔리페나신은 절박성 뇨실금, 빈뇨, 요절박과 같은 과민성방광 증상의 치료제로 사용되며
이성질체 분석은 CHIRALPAK IC로 가능합니다.
관련 문헌은 아래와 같으며 첨부파일을 통해 자세히 확인할 수 있습니다.
Development and Validation of New ChromatographicMethod
for the Determination of Enantiomeric and Diastereomeric
Purity of Solifenacin Succinate: An Antimuscarinic Agent
A new, simple, and rapid stereoselective normal phase-liquid chromatographic (NP-LC) method was developed to separate
and quantify the solifenacin succinate and its three stereoisomers. The stereoisomeric separation was achieved on Chiralpak IC
(250 × 4.6mm ID) column. The mobile phase was consisting of n-hexane, ethanol, isopropyl alcohol, and diethylamine in the
ratio (60 : 15 : 25 : 0.1, v/v/v/v), and the flow rate was maintained at 1.0mLmin−1. UV detection was carried out at 220 nm. In
addition, chiroptical detection was carried out using laser polarimeter to understand the elution orders. Resolution between all the
stereoisomers was not less than 3. Effect of column temperature on resolution between the stereoisomers was studied. The method
was validated as per ICH guideline and found to be robust. The proposed NP-LC method was successfully applied to the analysis
of commercial formulation. The method could be of use not only for routine evaluation of the quality of solifenacin succinate in
bulk drug manufacturing unit but also for detection of impurities in pharmaceutical formulations.
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