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 was carried out at 267 nm. FLB was retained at 4.656 ± 0.15 min and SER at 7.482 ± 0.18 min, respectively. A linear response was observed over 0.5–11 μg/mL using 1/x2 weighted linear regression. Further, the method was validated with respect to selectivity, accuracy, precision, recovery, stability, and carry over as per US-FDA guidance for bioanalytical method validation.
Faculty of Pharmaceutical Sciences, Chulalongkorn University
Sonawane, Sandeep S.; Shinde, Priyanka T.; Joshi, Gayatri S.; and Kshirsagar, Sanjay J.
"Development and Validation of High-
performance Liquid Chromatography
Method for Estimation of Seratrodast in
Spiked Human Plasma,"
The Thai Journal of Pharmaceutical Sciences: Vol. 45:
5, Article 8.
Available at: https://digital.car.chula.ac.th/tjps/vol45/iss5/8