ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SALBUTAMOL SULPHATE, GUAIFENESIN, AND AMBROXOL HYDROCHLORIDE BY RP-HPLC METHOD IN COMMERCIAL ORAL LIQUID DOSAGE FORMAbstract
Salbutamol is a bronchodilator, Guaifenesin is an expectorant and Ambroxol is a mucolytic. Combination of these drugs is used in the formulation of cough syrups. In the literature, there is no method reported for the simultaneous estimation of the drugs in oral liquid dosage form. Hence, the present work is aimed to develop reverse phase HPLC method for the simultaneous determination of Salbutamol sulfate (SAL), Guaifenesin (GUA) and Ambroxol hydrochloride (AMB) in oral liquid dosage form and validation of the developed method. The chromatographic separation of the drugs was achieved with the mobile phase system sodium dihydrogen phosphate buffer pH 3.0: acetonitrile: methanol in the ratio of 65:10:25 with the flow rate of 1 mL/min and injection volume 10 µL. An Inertsil C8-3 (250 × 4.6 mm, 5 µm) column was used, and the detection wavelength was 276 nm. This system produced sharp peaks with good resolution, minimum tailing and satisfactory retention times of SAL, GUA and AMB were found to be 3.157, 9.949 and 11.883 min respectively indicating the suitability of the system. The developed method was validated for various parameters accuracy, precision, linearity, robustness, and specificity as per ICH guidelines.
P. Thangavelu *, A. C. Grace and J. Murugesan
Department of Pharmaceutical Analysis, Nandha College of Pharmacy, Koorapalayam Pirivu, Pitchandam Palayam Post, Erode, Tamil Nadu, India.
13 May 2018
25 June 2018
02 July 2018
01 January 2019