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<strong>Simultaneous quantification of Daclatasvir and Sofosbuvir in human plasma and pharmacokinetic study by LCMS/MS</strong>

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Title Statement <strong>Simultaneous quantification of Daclatasvir and Sofosbuvir in human plasma and pharmacokinetic study by LCMS/MS</strong>
 
Added Entry - Uncontrolled Name Jaiswal, Amarnath ; Department of Chemistry, PAHER University, Udaipur-313003 (Raj.) India Clinical Research Centre, Mylan Laboratories Ltd. Hyderabad, 500062 India
 
Uncontrolled Index Term Bioequivalence; Daclatasvir; Good clinical practice; High performance liquid chromatography; Liquid Chromatography; Lower limit of quantification; Mass Spectrometry; Sofosbuvir
 
Summary, etc. <table class="table itemDisplayTable"><tbody><tr><td class="metadataFieldValue">In the treatment of hepatitis C, direct-acting antivirals (DAA) are highly efficient and well tolerated with a series of DAA combinations available for treatment. A sensitive high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed and validated for the simultaneous quantification of Sofosbuvir (SOF) and Daclatasvir (DAC) in human plasma. Sofosbuvir D6 (SOF D6) and Daclatasvir <span>13</span>C<span>2</span><span>2</span>H<span>6 </span>(DAC <span>13</span>C<span>2</span><span>2</span>H<span>6) </span>are used as internal standard (IS). Quantification for both the analytes has been attained with MS-MS detection in positive ion mode using an Acquity UPLC system (Waters) equipped with Waters Xevo TQ MS system with a Gemini NX 5µ C18 (50 × 2.0mm) (Phenomenex) column, and a gradient mobile phase consisting 5 mM Ammonium Formate buffer: Acetonitrile at a flow rate of 0.300 mL/min is used as mobile phase to separate the analytes and detection is performed by electrospray ionization technique using the mass spectrometer. Full validation is performed for bio-analytical methods with respect to linearity, precision, accuracy, selectivity, carry-over, stability and dilution integrity. Linearity is obtained over a concentration range of 10.002 -3000.488 and 10.004 -3001.218 ng mL<span>-1</span> for SOF and DAC respectively by applying weighted least-squares linear regression method (1/<em>x</em>2). The developed method was applied successfully in bioequivalence and/or clinical studies in 48 male subjects for the simultaneous quantification of SOF and DAC.</td></tr></tbody></table><p><br /><br /></p>
 
Publication, Distribution, Etc. Indian Journal of Chemical Technology (IJCT)
2021-03-22 13:54:27
 
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http://op.niscair.res.in/index.php/IJCT/article/view/44228
 
Data Source Entry Indian Journal of Chemical Technology (IJCT); ##issue.vol## 28, ##issue.no## 1 (2021): Indian Journal of Chemical Technology
 
Language Note en