Simultaneous determination of multi drug components theophylline, etofylline, guaiphenesine and ambroxol hydrochloride by validated RP-HPLC method in liquid dosage form

ABSTRACT

The RP-HPLC [reverse phase high performance liquid chromatography] method was developed and validated for simultaneous determination of Multi drug components i.e., Theophylline, Etofylline, Guaiphenesine and Ambroxol Hydrochloride in a liquid dosage form. Chromatographic separation of the four drugs was performed on a Hypersil Phenyl BDS [25cmX4.6mm, 5um]. The mobile phase constituted of triethylamine pH 3.0 buffer methanol [8515] v/v was delivered at the flow rate 1.5 mL/min. Detection was performed at 235 nm. The peak purity of Theophylline, Etofylline, Guaiphenesine and Ambroxol Hydrochloride were 0.99970, 0.99979, 0.99986 and 0.99949 respectively. Calibration curves were linear with correlation coefficient between 0.99995 to 0.99997 over a concentration range of 5 to 37 micro g/mL for Theophylline, 19 to 140 micro g/mL for Etofylline, 20 to 149 micro g/mL for Guaiphenesine and 6 to 45 micro g/mL for Ambroxol hydrochloride. The relative standard deviation [RSD] was found < 2.0%. The percentage recovery was found between th e range of 98.6% and 100.5% at three different levels. Robustness and ruggedness were performed and result found within the RSD of 2%. All the parameters of validation were found in the acceptance range of ICH guideline