Analytical Method Development and Validation for Simultaneous Estimation of Ambroxol HCL and Levocetrizine in Its Bulk and Dosage Form by RP-HPLC

R. Vivek*, Dr. T. Rama Mohan Reddy, Dr. V. Uma Maheswara Rao
Department of Pharmaceutical Analysis and Quality Assurance, CMR College of Pharmacy, Medchal, Hyderabad, Rangareddy, India

A B S T R A C T
A simple Reverse phase liquid chromatographic method has been developed and subsequently validated for simultaneous determination of Levocetirizine and Ambroxol HCl in combination. The separation was carried out using a mobile phase consisting of methanol:  potassium dihydrogen phosphate 50:50v/v (pH=3 adjusted with ortho phosphoric acid). The column used was inertsil. C18 BDS, 5µ,( 250 mm x 4.6 mm) id with flow rate of 1 ml / min using UV detection at 225 nm. The described method was linear over a concentration range of 0.5-3.5 µg/ml, 3-21 µg/ml and for the Levocetirizine, and Ambroxol HCl respectively. The retention times of Levocetirizine, and Ambroxol HCl were found to be 2.2 and 3.6 min respectively. Results of analysis were validated according to International Conference on Harmonization ICH Q2B guidelines statistically, and by recovery studies. The limit of detection (LOD) for Levocetirizine, and Ambroxol HCl were found to be 0.57 µg ml, 0.56 µg ml respectively. The limit of quantification (LOQ) was found to be 1.69 µg, 1.74 µg ml- for Levocetirizine, and Ambroxol Hcl respectively. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Levocetirizine, and Ambroxol Hcl bulk drug and in its pharmaceutical dosage form.
Keywords: RP-HPLC, levocetrizine, ambroxol, validation