RP-HPLC-UV analytical method development and validation of guaifenesin and ambroxol in pharmaceutical dosage form

Guaifenesin and Ambroxol in pharmaceutical dosage form can now be quantitatively analysed using a reverse phase high-performance liquid chromatography (RP-HPLC) technology that is easy to use, quick, accurate, sensitive, and repeatable. Chromatographic separation of Guaifenesin and Ambroxol was achieved on Waters Alliance-e2695 by using an Inertsil ODS (250x 4.6mm, 5μ) column and the mobile phase containing Methanol: 0.1% TFA in a ratio of 20:80% v/v. The flow rate was 1.0 ml/min, and a photodiode array detector operating at room temperature was used to detect the absorption at 231 nm. Guaifenesin and Ambroxol have theoretical plate counts of NLT 2000 and tailing factors that shouldn't exceed 2, respectively. All measurements have a relative standard deviation of peak areas consistently smaller than 2.0. In compliance with ICH guidelines, the suggested approach was validated. For the quantitative analysis of Guaifenesin and the stability research of Ambroxol, the method was determined to be straightforward, cost-effective, appropriate, exact, accurate, and robust.