Development of a Robust UPLC Method for Simultaneous Determination of a Novel Combination of Sofosbuvir and Daclatasvir in Human Plasma: Clinical Application to Therapeutic Drug Monitoring
المؤلفون المشاركون
Al-Tannak, Naser F.
Hemdan, Ahmed
Eissa, Maya S.
المصدر
International Journal of Analytical Chemistry
العدد
المجلد 2018، العدد 2018 (31 ديسمبر/كانون الأول 2018)، ص ص. 1-9، 9ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2018-10-21
دولة النشر
مصر
عدد الصفحات
9
التخصصات الرئيسية
الملخص EN
A rapid and selective UPLC-DAD method was developed and validated for simultaneous analysis of the novel two-drug combination Darvoni® for the treatment of HCV: Sofosbuvir (SF)/Daclatasvir (DC) in human plasma using Ledipasvir as internal standard (IS) where the extraction process was conducted using automated SPE.
Although the analysis of the combination after concomitant oral intake of two tablets of SF and DC individually was reported in literature, yet simultaneous analysis of this new combination in human plasma after a single oral dose was not previously reported.
The adopted chromatographic separation was achieved on Waters® Acquity UPLC BEH C18 column (2.1 × 50 mm, 1.7 µm) as a stationary phase using isocratic elution using a mobile phase system of ammonium formate (pH 3.5; 5 mM) and acetonitrile (60:40 v/v) pumped at a flow rate of 0.2 mL.min−1.
The UV detection was carried out at 261 nm for SF and 318 nm for DC and IS.
SF was eluted at 1.123 min while DC was eluted at 3.179 min.
The proposed chromatographic method was validated in accordance with guidelines of FDA for bioanalytical method validation.
A linear range was achieved in the range of 25-6400 and 50-12800 ng.mL−1 for SF and DC, respectively.
The proposed UPLC-DAD method was found to be accurate with % bias ranging between -10.0-7.2 for SF and -6.9-8.0 for DC.
Also it was proved to be precise with % CV for intraday precision ranging between 3.8-9.6 for SF and 2.8-9.2 for DC whereas interday precision ranged between 5.1-9.3 for SF and 3.7-9.1 for DC.
Moreover, % extraction recovery ranged between 90.0-107.2 for SF and 93.1-108.0 for DC using the suggested method.
The adopted chromatographic method was successfully applied to the therapeutic drug monitoring of SF and DC in healthy volunteers after the oral intake of one Darvoni® tablet.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Al-Tannak, Naser F.& Hemdan, Ahmed& Eissa, Maya S.. 2018. Development of a Robust UPLC Method for Simultaneous Determination of a Novel Combination of Sofosbuvir and Daclatasvir in Human Plasma: Clinical Application to Therapeutic Drug Monitoring. International Journal of Analytical Chemistry،Vol. 2018, no. 2018, pp.1-9.
https://search.emarefa.net/detail/BIM-1166476
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Al-Tannak, Naser F.…[et al.]. Development of a Robust UPLC Method for Simultaneous Determination of a Novel Combination of Sofosbuvir and Daclatasvir in Human Plasma: Clinical Application to Therapeutic Drug Monitoring. International Journal of Analytical Chemistry No. 2018 (2018), pp.1-9.
https://search.emarefa.net/detail/BIM-1166476
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Al-Tannak, Naser F.& Hemdan, Ahmed& Eissa, Maya S.. Development of a Robust UPLC Method for Simultaneous Determination of a Novel Combination of Sofosbuvir and Daclatasvir in Human Plasma: Clinical Application to Therapeutic Drug Monitoring. International Journal of Analytical Chemistry. 2018. Vol. 2018, no. 2018, pp.1-9.
https://search.emarefa.net/detail/BIM-1166476
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1166476
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر