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Saudi Pharm J. 2011 Jul;19(3):185-91. doi: 10.1016/j.jsps.2011.03.004. Epub 2011 Apr 01.

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

Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society

Md Faiyazuddin, Abdul Rauf, Niyaz Ahmad, Sayeed Ahmad, Zeenat Iqbal, Sushma Talegaonkar, Aseem Bhatnagar, Roop K Khar, Farhan J Ahmad

Affiliations

  1. Formulation Research Laboratory, Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, Hamdard Nagar, New Delhi 110 062, India ; Faculty of Pharmacy, Integral University, Dasauli, Kursi Road, Lucknow 222 026, Uttar Pradesh, India.

PMID: 23960758 PMCID: PMC3745045 DOI: 10.1016/j.jsps.2011.03.004

Abstract

Terbutaline sulfate (TBS) was assayed in biological samples by validated HPTLC method. Densitometric analysis of TBS was carried out at 366 nm 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 (r (2) ⩾ 0.9943) in the tested range of 100-1000 ng spot(-1) with a limit of quantification of 18.35 ng spot(-1). Drug recovery from biological fluids averaged ⩾95.92%. In both matrices, rapid degradation of drug favored and the T 0.5 of drug ranged from 9.92 to 12.41 h at 4 °C and from 6.31 to 9.13 h at 20 °C. Frozen at -20 °C, this drug was stable for at least 2 months (without losses >10%). The maximum plasma concentration (Cpmax) was found to be 5875.03 ± 114 ng mL(-1), which is significantly higher than the maximum saliva concentration (Csmax, 1501.69 ± 96 ng mL(-1)). Therefore, the validated method could be used to carry out pharmacokinetic studies of the TBS from novel drug delivery systems.

Keywords: Biological fluids; Ex vivo stability; High-performance thin-layer chromatography; Pharmacokinetic study; Terbutaline sulfate

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