New Stability Indicating Analytical Method Development and Validation for the Simultaneous Estimation of Azithromycin and Ambroxol Hydrochloride in Bulk and Tablet Dosage Form Using RP-HPLC

A simple, economic, rapid, high range and accurate stability indicating RP-HPLC method was development for simultaneous estimation of Azithromycin and Ambroxol Hydrochloride in their combined tablet dosage form. This method was carried out by using Isocratic peak HPLC instrument with kromasil C-18 Column (250 mm X 4.6mm,5um) with mobile phase consisting a mixture of Methanol: Acetonitrile: Phosphate buffer in the ratio of 70:20:10 (v/v), at a flow rate of 1.1 ml/min with UV detection at 221nm . The retention time for Azithromycin and Ambroxol Hydrochloride are 9.08 and 5.39min respectively. Suitability, specificity, linearity, accuracy, precision, stability, and sensitivity of this method for the quantitative determination of the drugs were proved by validation in accordance with the requirements laid down by International Conference on Harmonization (ICH) Q2 (R1) guidelines. To establish stability indicating nature of the LC method, forced degradation of drug substances was performed under stress conditions like thermal, oxidation, peroxide, UV light, acid and base hydrolysis) The limit of quantification (L.O.Q) for Azithromycin and Ambroxol Hydrochloride are found to be 0.70ug/ml 1.00ug/ml.Then the limit of detection (L.O.D) for Azithromycin and Ambroxol Hydrochloride are found to be 0.15ug/ml and 0.3ug/ml respectively. The results of the study showed that the proposed method is reliable and robust and can be used as quality control tool for the estimation of these drugs in combined pharmaceutical solid dosage forms.