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Improved simultaneous quantitation of candesartan and hydrochlorthiazide in human plasma by UPLC–MS/MS and its application in bioequivalence studies

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Journal of Pharmaceutical Analysis 2014年第2期4卷 144-152页

作者： Bhupinder Singh Rama S.Lokhandae Ashish Dwivedi Sandeep Sharma naveen dubey Jubiliant Clinsys Limited NoidaNew DelhiIndia Jaipur National University JaipurIndia

A validated ultra-performance liquid chromatography mass spectrometric method （UPLC-MS/MS） was used for the simultaneous quantitation of candesartan （CN） and hydrochlorothiazide （HCT） in human plasma. The analysis was performed on UPLC-MS/MS system using turbo ion spray interface. Negative ions were measured in multiple reaction monitoring （MRM） mode. The analytes were extracted using a liquid-liquid extraction （LLE） method by using 0.1 mL of plasma volume. The lower limit of quantitation for CN and HCT was 1.00 ng/mL whereas the upper limit of quantitation was 499.15 ng/mL and 601.61 ng/mL for CN and HCT respectively. CN d4 and HCT-13Cd2 were used as the internal standards for CN and HCT respectively. The chromatography was achieved within 2.0 min run time using a C18 Pheno-menex, Gemini NX （100 mm ~ 4.6 mm, 5 mm） column with organic mixture：buffer solution （80：20, v/v） at a flow rate of 0.800 mL/min. The method has been successfully applied to establish the bioequivalence of candesartan cilexetil （CNC） and HCT immediate release tablets with reference product in human subjects.

关键词： Candesartan cilexetil Hydrochlorothiazide UPLC MS/MS Bioequivalence Candcsartan cilexetil-hydrochlorothiazide(ATACAND HCT)

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Ultra-performance liquid chromatography electrospray ionization-tandem mass spectrometry method for the simultaneous determination of itraconazole and hydroxy itraconazole in human plasma

引用

Journal of Pharmaceutical Analysis 2014年第5期4卷 316-324页

作者： Ashish Dwivedi Bhupinder Singh Sandeep Sharma R.S.Lokhandae naveen dubey Bioanalytical Department Jubilant Life SciencesC-46Sector 62Noida 201307India Jaipur National University JaipurIndia

A highly sensitive, selective, and precise ultra-performance liquid chromatography tandem mass spectrometry method was developed and validated for simultaneous quantification of itraconazole and hydroxy itraconazole in human plasma by a single liquid-liquid extraction step. The precursor to product ion transitions of m/z 705.3/392.3, m/z 721.2/408.3 and m/z 708.2/435.4 were used to detect and quantify itraconazole, hydroxy itraconazole and itraconazole-d3 respectively. The lower limit of quantitation was found to be 0.500 ng/mL for itraconazole and 1.00 ng/mL for hydroxy itraconazole. The mean recoveries for itraconazole and hydroxy itraconazole were found to be 100.045% and 100.021%, respectively. This developed method with a chromatographic run time of 2.0 min was successfully applied to a bioequivalence study of 100 mg itraconazole capsule.

关键词： Itraconazole,Hydroxy itraconazole,Ultra-performance liquidchromatography, Human plasma Simultaneous analysis

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