Method development and validation for the simultaneous estimation of ambroxol HCL and levofloxacin by using RP HPLC method

Abstract

A new, simple, precise, accurate and reproducible RP -HPLC method for Simultaneous estimation of bulk and pharmaceutical formulations. Separation of Ambroxol HCL and levofloxacin   was successfully achieved by Inertsil C18, 250 X4.6, 5µm or equivalent in an isocratic mode utilizing 0.1% OPA: methanol (60:40) at a flow rate of 1mL/min and eluate was monitored at 238nm, with a retention time of 2.173 and 4.344 minutes for Ambroxol HCL and levofloxacin respectively. The method was validated and there response was found to be linear in the drug concentration range of 50µg/ml to150 µg/ml for Ambroxol HCL  and  50µg/ml to150 µg/ml for Levofloxacin. The values of the correlation coefficient were found to0.999for Ambroxol HCL and 1for levofloxacin respectively. The LOD and LOQ for Ambroxol HCL were found to be 0.035and 0.116 respectively. The LOD and LOQ for Levofloxacin were found to be 0.1884 and 0.6281 respectively. This method was found to be good percentage recovery for Ambroxol HCL and Levofloxacin were found to be 99.1% and 99.7% respectively indicates that the proposed method is  highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness