STABILITY INDICATING RP – HPLC METHOD FOR COMBINATION OF AMBROXOL HYDROCHLORIDE AND CEFADROXIL MONOHYDRATE IN PHARMACEUTICAL FORMULATIONAbstract
Reverse Phase – High performance liquid chromatographic (RP – HPLC) method was described for determination of Ambroxol Hydrochloride (AMB) and Cefadroxil Monohydrate (CEFXL). The chromatographic separation was achieved using mobile phase mixture of Acetonitrile and 0.05 M Dihydrogen Phosphate Buffer (pH 3.0 adjusted with Ortho Phosphoric Acid Solution) in the ratio of 40:60 (%v/v) and Eclipse Plus C18, (150 x 4.6 mm i.d), Particle size 5 mm column at 1.0 ml/min flow rate. 20 µL of standard preparation containing 30 µg/ml AMB and 250 µg/ml CEFXL was injected into the column and the component was separated by carrying out elution for a run time of 15 minutes and detected at 230 nm wavelength. The described method shows excellent linearity over a range of 6 to 60 μg/ml and 50 to 500 μg/ml for AMB and CEFXL, respectively. AMB and CEFXL were subjected to stress degradation conditions of hydrolysis (acid and base), oxidation and thermal degradation. Stressed samples were analysed by the developed method. The proposed method was readily applied for the assay of pharmaceutical formulations and the results were found to be accepted, therefore the proposed method can be adopted for the routine analysis of any quality control laboratory.
J. A. Goswami * and N. J. Shah
Quality Assurance Department, School of Pharmacy, RK University, Rajkot, Gujarat, India
25 August, 2016
26 November, 2016
28 November, 2016
01 March, 2017