دورية أكاديمية

Validated liquid chromatography-tandem mass spectrometry method for simultaneous determination of clopamide, reserpine and dihydroergotoxine: Application to pharmacokinetics in human plasma.

التفاصيل البيبلوغرافية
العنوان: Validated liquid chromatography-tandem mass spectrometry method for simultaneous determination of clopamide, reserpine and dihydroergotoxine: Application to pharmacokinetics in human plasma.
المؤلفون: Sharaf El-Din MM; Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Mansoura University, Dakahlia, Egypt., Nassar MW; Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt., Attia KA; Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt., Demellawy MA; Pharmaceutical & Fermentation Industries Development Center, City of Scientific Research and Technology Applications, New Borg El-Arab 21934, Alexandria, Egypt., Kaddah MM; Pharmaceutical & Fermentation Industries Development Center, City of Scientific Research and Technology Applications, New Borg El-Arab 21934, Alexandria, Egypt. Electronic address: mmkaddah1978@gmail.com.
المصدر: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2016 Jun 05; Vol. 125, pp. 236-44. Date of Electronic Publication: 2016 Mar 25.
نوع المنشور: Journal Article; Validation Study
اللغة: English
بيانات الدورية: Publisher: Elsevier Science Country of Publication: England NLM ID: 8309336 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-264X (Electronic) Linking ISSN: 07317085 NLM ISO Abbreviation: J Pharm Biomed Anal Subsets: MEDLINE
أسماء مطبوعة: Publication: <2006->: London : Elsevier Science
Original Publication: Oxford ; New York : Pergamon Press, c1983-
مواضيع طبية MeSH: Chromatography, Liquid/*methods , Clopamide/*blood , Dihydroergotoxine/*blood , Reserpine/*blood , Tandem Mass Spectrometry/*methods, Clopamide/pharmacokinetics ; Dihydroergotoxine/pharmacokinetics ; Humans ; Limit of Detection ; Reproducibility of Results ; Reserpine/pharmacokinetics
مستخلص: A simple, sensitive and rapid high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method was developed and validated for the simultaneous quantitation of clopamide, reserpine and dihydroergotoxine (ergoloid mesylates) in human plasma. Under basic conditions, liquid-liquid extraction using ethyl acetate was efficiently used for extraction of the analytes from plasma samples in presence of indapamide as internal standard (IS). The analytes were separated with isocratic elution on Phenomenex(®) Synergi Fusion-RP 80A column (50×4.6mm, 4μm). With positive ion electrospray ionization (ESI), the analytes were quantified and monitored on a triple quadrupole mass spectrometer using Multiple Reaction Monitoring (MRM) scanning mode. Satisfactory results regarding linearity, recovery, stability, accuracy and precision of the analytes were obtained. The method was linear in the concentration range of 0.04-30.00ng/mL for reserpine, 1-96.00ng/mL for clopamide, and 0.05-40.00ng/mL for dihydroergotoxine alkaloids, respectively. For all analytes, the high sensitivity of HPLC-MS/MS method revealed sufficient lower limit of quantification (LLOQ) ranged from 0.04-1ng/mL using 1mL of plasma. The recoveries from spiked control samples were ≥86.16% for all analytes and IS. The intra- and inter-day precision variations were lower than 13.03% while the accuracy values ranged from 91.76% to 111.50%. The developed method was successfully applied to pharmacokinetic study of fixed dose combination of clopamide, reserpine and dihydroergotoxine in healthy male volunteers.
(Copyright © 2016 Elsevier B.V. All rights reserved.)
فهرسة مساهمة: Keywords: Clopamide; Dihydroergotoxine; Ergoloid mesylates; HPLC–MS/MS; Pharmacokinetics; Reserpine
المشرفين على المادة: 11032-41-0 (Dihydroergotoxine)
17S83WON0I (Clopamide)
8B1QWR724A (Reserpine)
تواريخ الأحداث: Date Created: 20160403 Date Completed: 20170411 Latest Revision: 20191210
رمز التحديث: 20221213
DOI: 10.1016/j.jpba.2016.03.051
PMID: 27037980
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-264X
DOI:10.1016/j.jpba.2016.03.051