{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T16:07:58Z","timestamp":1781626078597,"version":"3.54.5"},"reference-count":34,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2018,1,29]],"date-time":"2018-01-29T00:00:00Z","timestamp":1517184000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Biomedical Chromatography"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>A simple and highly sensitive liquid chromatography\u2013tandem mass spectrometry (LC\u2010MS\/MS) bioanalytical method was developed and fully validated for the first time for the simultaneous determination of newly discovered antiviral drugs, namely sofosbuvir (SOF) and daclatasvir (DAC) in human plasma. Tadalafil (TAD) was used as internal standard (IS). SOF, DAC and TAD (IS) were extracted from plasma using liquid\u2013liquid extraction technique with methyl <jats:italic>tert<\/jats:italic>\u2010butyl ether. The chromatographic separation was carried out using ZorbaxSB\u2010C<jats:sub>18<\/jats:sub> column (4.6 \u00d7 50\u2009mm,5\u2009\u03bcm) and 5\u2009m<jats:sc>m<\/jats:sc> ammonium formate buffer (pH\u20093.5)\u2013acetonitrile (50:50, v\/v) as mobile phase in an isocratic elution mode pumped at a flow rate 0.7\u2009mL min<jats:sup>\u22121<\/jats:sup>. The quantitation was performed on API4500 triple quadrupole tandem mass spectrometer with positive electrospray ionization interface in multiple reaction monitoring mode. Validation was applied according to US Food and Drug Administration guidelines for bio\u2010analytical methodswith respect to linearity, precision, accuracy, selectivity, carry\u2010over, stability and dilution integrity. Linearity was obtained over concentration ranges of 0.3\u20133000 and 3\u20133000\u2009ng mL<jats:sup>\u22121<\/jats:sup> for SOF and DAC, respectively, by applying a weighted least\u2010squares linear regression method (1\/<jats:italic>x<\/jats:italic><jats:sup>2<\/jats:sup>). The proposed method could be applied successfully in bioequivalence and\/or clinical studies for therapeutic drug monitoring of patients undergoing dual combination therapy as the latter combination proved more efficacious and powerful tool for the complete treatment of hepatitis C genotype 3 within 16\u2009weeks. The suggested method has been applied successfully to pharmacokinetic studies with excellent assay ruggedness and reproducibility.<\/jats:p>","DOI":"10.1002\/bmc.4186","type":"journal-article","created":{"date-parts":[[2018,1,3]],"date-time":"2018-01-03T22:36:54Z","timestamp":1515019014000},"source":"Crossref","is-referenced-by-count":39,"title":["Development and validation of LC\u2010MS\/MS method for simultaneous determination of sofosbuvir and daclatasvir in human Plasma: Application to pharmacokinetic study"],"prefix":"10.1002","volume":"32","author":[{"given":"Ola M.","family":"Abdallah","sequence":"first","affiliation":[{"name":"Analytical Chemistry Department, Faculty of Pharmacy Al\u2010Azhar University (Girls)  Cairo Egypt"},{"name":"Pharmaceutical Chemistry Department, Faculty of Pharmacy Badr University in Cairo (BUC)  Badr City Cairo Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0180-0918","authenticated-orcid":false,"given":"Ahmed M.","family":"Abdel\u2010Megied","sequence":"additional","affiliation":[{"name":"Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy and Pharmaceutical Manufacturing Kafrelsheikh University  Kafrelsheikh City Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amira S.","family":"Gouda","sequence":"additional","affiliation":[{"name":"Zi\u2010diligence Research Center  Cairo Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,1,29]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2017.06.005"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2016.04.031"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1039\/C6RA25826C"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharma.2016.12.005"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1021\/jm401836p"},{"key":"e_1_2_7_7_1","unstructured":"Bifano M. Sevinsky H. Persson A. Chung E. Wind\u2010Rotolo M. Hwang C. ...Bertz R. (2011).Single\u2010dose pharmacokinetics of Daclatasvir (DCV; BMS\u2010790052) in subjects with hepatic impairment compared with healthy subjects. Paper presented at the62th Annual meeting of the American Association for the Study of Liver Diseases San Francisco CA."},{"key":"e_1_2_7_8_1","unstructured":"Bristol\u2010Myers\u2010Squibb(2014).Daklinza (daclatasvir) summary of product characteristics. European Union."},{"key":"e_1_2_7_9_1","unstructured":"Eley T. You X. Huang S.\u2010P. Symonds W. Sherman D. Mathias A. ...Bertz R.(2013).Evaluation of drug interaction potential between daclatasvir and sofosbuvir. Presented at8th Interational workshop on clinical pharmacology of heapatits therapy Cambridge. 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