The main objective of the current analysis was to develop and evaluate a simple, rapid, sensitive and stable reverse-phase of high-performance liquid chromatography (RP-HPLC) method for a combination of Terbutaline sulphate (TSL), Guaifenesin (GFN) and Ambroxol hydrochloride (AML).

These three-drug combinations were analysed by using Shimadzu LC 2010 CHT high performance liquid chromatography (HPLC). Successful separation was attained by isocratic elution on a reverse-phase C18 column (250mm, 4.6mm, 5μ), by using a mobile phase that consisted of buffer: acetonitrile in the ratio 80: 20 followed by 1.0mL/min flow rate. The wavelength of recognition was at 220nm.

The chromatographic maintenance times were consistent at 3.0 minutes for TSL, 10.5 minutes for AML and 13.8 minutes for GFN respectively. For these three compounds, the lower limit of recognition was 1.0, 1.25, and 1.5μg/mL. And the lower limit of quantification was 3.3, 4.1 and 5.0μg/mL respectively. The linearity concentration for TSL was at 1.0-7.0, AML at 1.5-7.5 and GFN at 4.0-14.0μg/mL. The association coefficients for all the drugs were greater than 0.999. The relative standard deviation of inter- and intra-day were < 2.0%. 

The analysis concluded that this method offers a necessary tool for quantification of the selected drugs for their evaluation. The projected method is simple, reproducible, accurate and applied successfully to analyse three compounds in pure and dosage form.

Source: Itagimatha N, Manjunatha DH. RP-HPLC-UV method development and validation for simultaneous determination of terbutaline sulphate, ambroxol HCl and guaifenesin in pure and dosage forms. Ann Pharm Fr. 2019 Jul;77(4):295-301. doi: 10.1016/j.pharma.2019.02.004. Epub 2019 Apr 23. PMID: 31027752.