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Bio-Analytical Method Development and Validation For The Concurrent Quantification of Hydrochlorothiazide And Valsartan By Using Losartan As Internal Standard In Human Plasma By LC-MS/MS
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| Author:
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JITHIN JOHN, NAGARAJAN JANAKI SANKARACHARI KRISHNAN, KRISHNAVENI R, TAMADRI DAS, ANN RAICHEL JOHN
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| Abstract:
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A simple, rapid, specific and sensitive method has been proposed for the development and validation of bio-analytical method for the concurrent quantification of hydrochlorothiazide and valsartan using losartan as an internal standard in human blood plasma by LC-MS/MS. The separation was achieved using ZORBAX SB C18 (5µmx50x3.6mm i.d.), mobile phase containing Cyanomethane: Ammonium Formate (70:30v/v) pH adjusted to 4.25 and flow rate of the mobile phase was 0.5ml/min and the injection volume 10µl and the column oven temperature is ambient. The retention time of hydrochlorothiazide (HCT) and valsartan (VST) was found to be 1.22 and 1.08min, respectively. The developed method was found to be linear over the concentration range of 420-8400 (r2 value 0.9932) and 6-122ng/ml (r2 value 0-9954) using losartan as internal standard. LOD and LOQ of valsartan 1 and 3ng/ml and that of hydrochlorothiazide was 0.5 and 2 ng/ml respectively. Shimadzu LC-MS/MS 8030 was configured with Lab solution data solution, Triple quadrupole analyzer, ESI interface. Hydrochlorothiazide and valsartan were extracted by Liquid-Liquid extraction method. According to USFDA guidelines the method was established and validated. This method can applicable for the Pharmacokinetic, Bioequivalence and Bioavailability studies contains valsartan and hydrochlorothiazide.
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| Keyword:
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Bio-analytical, Human Plasma, Valsartan, Hydrochlorothiazide, LC-MS/MS.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.02.0007
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| Download:
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