Bhatt Nejal M, Chavada Vijay D, Patel Daxesh P, Sharma Primal, Sanyal Mallika, Shrivastav Pranav S
Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad 380009, Gujarat, India.
Department of Chemistry, St. Xavier׳s College, Navrangpura, Ahmedabad 380009, Gujarat, India.
J Pharm Anal. 2015 Feb;5(1):1-11. doi: 10.1016/j.jpha.2014.08.001. Epub 2014 Aug 12.
A simple, rapid and sensitive ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed for the simultaneous determination of cilostazol and its pharmacologically active metabolite 3,4-dehydro cilostazol in human plasma using deuterated analogs as internal standards (ISs). Plasma samples were prepared using solid phase extraction and chromatographic separation was performed on UPLC BEH C (50 mm×2.1 mm, 1.7 µm) column. The method was established over a concentration range of 0.5-1000 ng/mL for cilostazol and 0.5-500 ng/mL for 3,4-dehydro cilostazol. Intra- and inter-batch precision (% CV) and accuracy for the analytes were found within 0.93-1.88 and 98.8-101.7% for cilostazol and 0.91-2.79 and 98.0-102.7% for the metabolite respectively. The assay recovery was within 95-97% for both the analytes and internal standards. The method was successfully applied to support a bioequivalence study of 100 mg cilostazol in 30 healthy subjects.
已开发出一种简单、快速且灵敏的超高效液相色谱 - 串联质谱法（UPLC-MS/MS），以氘代类似物作为内标物（ISs），用于同时测定人血浆中西洛他唑及其药理活性代谢物3,4 - 脱氢西洛他唑。血浆样品采用固相萃取法制备，色谱分离在UPLC BEH C（50 mm×2.1 mm，1.7 µm）柱上进行。该方法建立的西洛他唑浓度范围为0.5 - 1000 ng/mL，3,4 - 脱氢西洛他唑浓度范围为0.5 - 500 ng/mL。西洛他唑的批内和批间精密度（% CV）及分析物的准确度分别在0.93 - 1.88和98.8 - 101.7%之间，代谢物的批内和批间精密度（% CV）及准确度分别在0.91 - 2.79和98.0 - 102.7%之间。分析物和内标的测定回收率均在95 - 97%之间。该方法成功应用于支持30名健康受试者中100 mg西洛他唑的生物等效性研究。
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