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	Application of an LC-MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for a bioequivalence study
	Shah Jaivik V; Parekh Jignesh M; Shah Priyanka A; Shah Priya V; Sanyal Mallika; Shrivastav Pranav S
来源期刊	Journal of Pharmaceutical Analysis
ISSN	2095-1779
出版年	2017
卷号	7 期号:5 页码:309-316
英文摘要	A sensitive and selective method has been proposed for the simultaneous determination of amlodipine (AML), valsartan (VAL) and hydrochlorothiazide (HCTZ) in human plasma by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The analytes and their deuterated analogs were quantitatively extracted from 100 muL human plasma by solid phase extraction on Oasis HLB cartridges. The chromatographic separation of the analytes was achieved on a Chromolith RP18e (100 mm * 4.6 mm) analytical column within 2.5 min. The resolution factor between AML and VAL, AML and HCTZ, and VAL and HCTZ was 2.9, 1.5 and 1.4, respectively, under isocratic conditions. The method was validated over a dynamic concentration range of 0.02-20.0 ng/mL for AML, 5.00-10,000 ng/mL for VAL and 0.20-200 ng/mL for HCTZ. Ion-suppression/enhancement effects were investigated by post-column infusion technique. The mean IS-normalized matrix factors for AML, VAL and HCTZ were 0.992, 0.994 and 0.998, respectively. The intra-batch and inter-batch precision (% CV) across quality control levels was ≤ 5.56% and the recovery was in the range of 93.4%-99.6% for all the analytes. The method was successfully applied to a bioequivalence study of 5 mg AML + 160 mg VAL + 12.5 mg HCTZ tablet formulation (test and reference) in 18 healthy Indian males under fasting. The mean log-transformed ratios of Cmax, AUC0-120h and AUC0-inf and their 90% CIs were within 90.2%-102.1%. The assay reproducibility was demonstrated by reanalysis of 90 incurred samples.
英文关键词	Amlodipine Valsartan Hydrochlorothiazide LC-MS/MS Polypill Bioequivalence
类型	Article
语种	英语
开放获取类型	Other Gold, Green Published
收录类别	CSCD
WOS研究方向	Pharmacology & Pharmacy
CSCD记录号	CSCD:6099319
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/335869
作者单位	Shah Jaivik V, Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad, India.; Parekh Jignesh M, Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad, India.; Shah Priyanka A, Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad, India.; Shah Priya V, Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad, India.; Shrivastav Pranav S, Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad, India.; Sanyal Mallika, Department of Chemistry, St. Xavier's College, Ahmedabad, 380009, India.
推荐引用方式 GB/T 7714	Shah Jaivik V,Parekh Jignesh M,Shah Priyanka A,et al. Application of an LC-MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for a bioequivalence study[J],2017,7(5):309-316.
APA	Shah Jaivik V,Parekh Jignesh M,Shah Priyanka A,Shah Priya V,Sanyal Mallika,&Shrivastav Pranav S.(2017).Application of an LC-MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for a bioequivalence study.Journal of Pharmaceutical Analysis,7(5),309-316.
MLA	Shah Jaivik V,et al."Application of an LC-MS/MS method for the analysis of amlodipine, valsartan and hydrochlorothiazide in polypill for a bioequivalence study".Journal of Pharmaceutical Analysis 7.5(2017):309-316.