Journal of Pharmaceutical and Biomedical Analysis 29 (2002) 927–937 Determination of terbutaline sulfate and its degradation products in pharmaceutical formulations using LC N. Daraghmeh a , M.M. Al-Omari a , Z. Sara a , A.A. Badwan a , A.M.Y. Jaber b, * a The Jordanian Pharmaceutical Manufacturing and Medical Equipment Co. Ltd, PO Box 94, Naor 11710, Jordan b Chemistry Department, King Fahd Uniersity of Petroleum and Minerals, Dhahran 31261, Saudi Arabia Received 14 November 2001; received in revised form 15 March 2002; accepted 1 April 2002 Abstract There is a lack of information concerning analysis of terbutaline sulfate and quantification of its related substances particularly in the liquid dosage forms. This work aimed at developing and validating an HPLC method for determination of terbutaline sulfate and its possible degradation products, namely, 3,5-dihydroxybenzoic acid, 3,5 dihydroxybenzaldehyde and 1-(3,5-dihydroxyphenyl)-2-[(1,1-dimethylethyl) amino]-ethanone that might appear as impurities in the starting material as well as in the solid and liquid formulations. The chromatographic system used consisted a Hypersil 100 C 18, 150 ×4.6 mm (5 m) column, a mobile phase of ammonium acetate (0.15 M) and glacial acetic acid (pH of 4.0, 96:4 v/v) with a flow rate of 2 ml min -1 and a UV detector set at 270 nm. The degree of linearity and the characteristic statistical parameters of the calibration curves including the limit of detection (LOD) and limit of quantitation (LOQ) were estimated for terbutaline sulfate and its degradation products. The method was found to be specific, stability indicating, accurate, precise and robust. © 2002 Elsevier Science B.V. All rights reserved. Keywords: Terbutaline sulfate; Chromatographic purity; Stability indicating assay; HPLC www.elsevier.com/locate/jpba 1. Introduction Terbutaline sulfate is a synthetic  2 -adrenocep- tor that is used as a bronchodilator in the treat- ment of bronchial asthma. It is known chemically as --[(tert -butylamino) methyl]-3,5-dihydroxy- benzyl alcohol sulfate. It exists as a racemic mix- ture and has the chemical structure shown below. HPLC methods were extensively used to quan- tify terbutaline sulfate in its dosage forms and as anticipated, these methods differ in columns used, * Corresponding author. Tel.: +966-3-860-2611; fax: + 966-3-860-4277. E-mail address: amjaber@kfupm.edu.sa (A.M.Y. Jaber). 0731-7085/02/$ - see front matter © 2002 Elsevier Science B.V. All rights reserved. PII:S0731-7085(02)00216-9