Itagimatha N, Manjunatha D H
Department of Chemistry, MS Ramaiah Institute of Technology, MS Ramaiah Nagar, MSRIT Post, 560 054 Bengaluru, India.
Department of Chemistry, MS Ramaiah Institute of Technology, MS Ramaiah Nagar, MSRIT Post, 560 054 Bengaluru, India.
Ann Pharm Fr. 2019 Jul;77(4):295-301. doi: 10.1016/j.pharma.2019.02.004. Epub 2019 Apr 23.
The objective of the present work was to develop and validate a simple, sensitive, rapid and stable reverse-phase high performance liquid chromatography (RP-HPLC) method for a combination of Terbutaline sulphate (TSL), Ambroxol hydrochloride (AML) and Guaifenesin (GFN).
The combination of these drugs was analyzed by using Shimadzu LC 2010 CHT high performance liquid chromatography (HPLC). Successful separation was achieved by isocratic elution on a reverse-phase C column (sun fire) (250mm, 4.6mm, 5μ), using a mobile phase consisting of buffer: acetonitrile in the ratio 80: 20 (buffer - 0.1% v/v triethyleamine pH-3.0) followed by 1.0mL/min flow rate. The wavelength of detection was at 220nm.
The chromatographic retention times were consistent at 3.0, 10.5 and 13.8minutes for TSL, AML and GFN respectively. For these three compounds, the lower limit of detection was 1.0, 1.25, and 1.5μg/mL and lower limit of quantification was 3.3, 4.1 and 5.0μg/mL respectively. The linearity concentrations established for TSL, AML and GFN were 1.0-7.0, 1.5-7.5 and 4.0-14.0μg/mL respectively. The correlation coefficients for all the drugs were found to be greater than 0.999. The relative standard deviation of inter- and intra-day were less than 2.0%.
This method provides a necessary tool for quantification of the selected drugs for their assay. The proposed method is simple, accurate, reproducible and applied successfully to analyze three compounds in pure as well dosage form.
本研究的目的是开发并验证一种简单、灵敏、快速且稳定的反相高效液相色谱（RP-HPLC）法，用于测定硫酸特布他林（TSL）、盐酸氨溴索（AML）和愈创甘油醚（GFN）的组合。
使用岛津LC 2010 CHT高效液相色谱（HPLC）对这些药物的组合进行分析。在反相C柱（Sun Fire）（250mm，4.6mm，5μm）上通过等度洗脱成功实现分离，流动相由缓冲液：乙腈按80:20的比例组成（缓冲液 - 0.1% v/v三乙胺，pH - 3.0），流速为1.0mL/min。检测波长为220nm。
TSL、AML和GFN的色谱保留时间分别为3.0、10.5和13.8分钟，保持一致。对于这三种化合物，检测下限分别为1.0、1.25和1.5μg/mL，定量下限分别为3.3、4.1和5.0μg/mL。TSL、AML和GFN建立的线性浓度分别为1.0 - 7.0、1.5 - 7.5和4.0 - 14.0μg/mL。所有药物的相关系数均大于0.999。日内和日间的相对标准偏差均小于2.0%。
该方法为所选定药物的定量测定提供了必要工具。所提出的方法简单、准确、可重现，并成功应用于分析纯品及剂型中的三种化合物。
