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International Journal for Research Trends and Innovation
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ISSN Approved Journal No: 2456-3315 | Impact factor: 8.14 | ESTD Year: 2016
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Impact Factor : 8.14
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| Paper Title: | Bioanalytical method development and validation of LC-ESI-MS/MS for estimation of Terazosin Hydrochloride Dihydrate in K3EDTA human plasma |
| Authors Name: | Patel Megha sunilbhai , Dr. Tulsidas Misra , Mr. Gajendra Solanki , Dr. Alisha Patel |
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| Author Reg. ID: |
IJRTI_189684
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| Published Paper Id: | IJRTI2404134 |
| Published In: | Volume 9 Issue 4, April-2024 |
| DOI: | |
| Abstract: | To develop and validate a Bioanalytical method LC-ESI-MS/MS for estimation terazosin hydrochloride dihydrate in K3EDTA human plasma. A simple, rapid and sensitive isocratic reverse - phase liquid Chromatography - tandem mass spectrometric method equipped with Turbo Ion Spray (TIS) source, operating in the Positive ion and Multiple Reaction Monitoring (MRM) mode was developed to quantify terazosin hydrochloride dihydrate in human plasma. Liquid Liquid extraction (LLE) method was followed to extract analyte and ISTD from human plasma. For separation Mobile Phase Composition was 0.01% formic acid in 10 mM ammonium formate in water: Methanol (50:50% v/v) by using of column Betasil C8,150×4.6mm, 5µm. The drug and ISTD retained at about 2.6 minute with total run time 5 minute. After optimization, the Bio-analytical method was validated according to ICH, USFDA and EMA guidelines for Bio-analysis. Sample preparation was performed using Liquid Liquid extraction (LLE) and this method yielded clean extracts with recovery of 91.16 and 100.24 % for Drug and ISTD respectively. The response of the LC-MS/MS method for analyte was linear over the dynamic range of 0.400 – 400.000 ng/ml with regression coefficient r2 were found in range of 0.9962 to 0.9996. The Accuracy was within the accepted limit of ± 20% at lower limit of quantification (LLOQ) and ± 15 % at all the other concentrations in the linear range. A simple, precise and sensitive isocratic reverse-phase liquid chromatographic tandem mass spectrometric method was developed to quantify Terazosin Hydrochloride Dihydrate in KEDTA human plasma and can be successfully applied for BA/BE, toxicokinetic and pharmacokinetic studies in human subjects. |
| Keywords: | LC-ESI-MS/MS, Terazosin Hydrochloride Dihydrate, liquid liquid extraction, plasma, BA/BE studies |
| Cite Article: | "Bioanalytical method development and validation of LC-ESI-MS/MS for estimation of Terazosin Hydrochloride Dihydrate in K3EDTA human plasma", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.9, Issue 4, page no.987 - 994, April-2024, Available :http://www.ijrti.org/papers/IJRTI2404134.pdf |
| Downloads: | 000205127 |
| ISSN: |
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator |
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Published Paper ID: IJRTI2404134
Registration ID:189684
Published In: Volume 9 Issue 4, April-2024
DOI (Digital Object Identifier):
Page No: 987 - 994 Country: vapi,valsad, Gujrat, India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijrti.org/viewpaperforall?paper=IJRTI2404134 Published Paper PDF: https://www.ijrti.org/papers/IJRTI2404134 |
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ISSN: 2456-3315
Impact Factor: 8.14 and ISSN APPROVED,
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