A validated HPTLC method for determination of terbutaline sulfate in biological samples: Application to pharmacokinetic study

AbstractTerbutaline sulfate (TBS) was assayed in biological samples by validated HPTLC method. Densitometric analysis of TBS was carried out at 366nm on precoated TLC aluminum plates with silica gel 60F254 as a stationary phase and chloroform–methanol (9.0:1.0, v/v) as a mobile phase. TBS was well resolved at RF 0.34±0.02. In all matrices, the calibration curve appeared linear (r2⩾0.9943) in the tested range of 100–1000ngspot−1 with a limit of quantification of 18.35ngspot−1. Drug recovery from biological fluids averaged ⩾95.92%. In both matrices, rapid degradation of drug favored and the T0.5 of drug ranged from 9.92 to 12.41h at 4°C and from 6.31 to 9.13h at 20°C. Frozen at −20°C, this drug was stable for at least 2months (without losses >10%). The maximum plasma concentration (Cpmax) was found to be 5875.03±114ngmL−1, which is significantly higher than the maximum saliva concentration (Csmax, 1501.69±96ngmL−1). Therefore, the validated method could be used to carry out pharmacokinetic studies of the TBS from novel drug delivery systems