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The Thai Journal of Pharmaceutical Sciences

2021

Method Validation

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Full-Text Articles in Life Sciences

Simultaneous Estimation Of Ivacaftor And Tezacaftor In Rat Plasma By Liquid Chromatography Coupled With Tandem-Mass-Spectrometry: Application To Pharmacokinetic Studies, M. Satya Venkata, A. Lakshmana Rao, M. William Carey Jan 2021

Simultaneous Estimation Of Ivacaftor And Tezacaftor In Rat Plasma By Liquid Chromatography Coupled With Tandem-Mass-Spectrometry: Application To Pharmacokinetic Studies, M. Satya Venkata, A. Lakshmana Rao, M. William Carey

The Thai Journal of Pharmaceutical Sciences

Background: Ivacaftor and Tezacaftor belong to the CFTR potentiator class, in combination approved to manage cystic fibrosis. Objective: To establish a sensitive LC-MS/MS approach for the synchronized analysis of Ivacaftor and Tezacaftor and its appliance to rat pharmacokinetic investigation. Methodology: Method is developed with protein precipitation by acetonitrile and Ivacaftor-d4, Tezacaftor-d4 are used as internal standards. Separation is done on an Eclipse plus C18 analysis column (100 mm × 4.6 mm 1.8 μm) with a mobile phase consisting of 0.1% trifluoroacetic acid: acetonitrile (ratio 60:40, v/v, and pH 2.5) and flow stream of 1.0 mL/min at ambient temperature. Results: The …


Development And Validation Of High- Performance Liquid Chromatography Method For Estimation Of Seratrodast In Spiked Human Plasma, Sandeep S. Sonawane, Priyanka T. Shinde, Gayatri S. Joshi, Sanjay J. Kshirsagar Jan 2021

Development And Validation Of High- Performance Liquid Chromatography Method For Estimation Of Seratrodast In Spiked Human Plasma, Sandeep S. Sonawane, Priyanka T. Shinde, Gayatri S. Joshi, Sanjay J. Kshirsagar

The Thai Journal of Pharmaceutical Sciences

In the work presented, an high-performance liquid chromatography method was developed and validated for the estimation of seratrodast (SER) in spiked human plasma, using flurbiprofen as an internal standard (IS). The drug and IS were extracted from pooled human plasma sample using 5 mL of tert-butyl methyl ether with 200 μL of 1% v/v formic acid. Both SER and IS were well separated and resolved from each other and plasma interferents using 20 mM phosphate buffer (pH 3.0) with acetonitrile in the proportion of 30: 70% v/v, in an isocratic mode at 1 mL/min on a C18 column and detection …