Development and Validation of HPLC Method for Estimation of Seratrodast in Spiked Human Plasma:(TJPS-2020-0192.R2)

In the work presented, an HPLC method was developed and validated for the estimation of seratrodast (SER) in spiked human plasma, using flurbiprofen (FLB) as an internal standard (IS). The drug and internal standard were extracted from pooled human plasma sample using 5 mL of tert-butyl methyl ether (TBME) 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/x 2 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.