Daraghmeh N, Al-Omari M M, Sara Z, Badwan A A, Jaber A M Y
The Jordanian Pharmaceutical Manufacturing and Medical Equipment Co. Ltd, PO Box 94, 11710, Naor, Jordan.
J Pharm Biomed Anal. 2002 Jul 31;29(5):927-37. doi: 10.1016/s0731-7085(02)00216-9.
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 x 4.6 mm (5 microm) 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.
关于硫酸特布他林的分析及其相关物质的定量，尤其是在液体制剂方面，信息匮乏。本研究旨在开发并验证一种高效液相色谱法，用于测定硫酸特布他林及其可能的降解产物，即3,5 - 二羟基苯甲酸、3,5 - 二羟基苯甲醛和1 - (3,5 - 二羟基苯基)-2 - [(1,1 - 二甲基乙基)氨基]-乙酮，这些物质可能作为起始原料以及固体和液体制剂中的杂质出现。所使用的色谱系统包括一根Hypersil 100 C(18,) 150 x 4.6 mm（5微米）的色谱柱，流动相为醋酸铵（0.15 M）和冰醋酸（pH为4.0，96:4 v/v），流速为2 ml min(-1)，紫外检测器设定在270 nm。对硫酸特布他林及其降解产物的线性程度以及校准曲线的特征统计参数，包括检测限（LOD）和定量限（LOQ）进行了评估。结果发现该方法具有专属性、稳定性指示性、准确性、精密度和耐用性。
