Ambroxol Hydrochloride

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.

A Reversed-Phase High Performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous determination of Ambroxol Hydrochloride and Cefpodoxime Proxetile in combined tablet dosage form. The analysis was carried out using Phenomenex Luna C – 18, pre-packed column. Mobile phase, containing Acetonitrile: 0.05 M Potassium Dihydrogen Ortho Phosphate Buffer (70:30) pH adjusted to 6.7 with Tri ethyl Amine was pumped at a flow rate of 1.0 mL/min with UV-detection at 245 nm. Retention time was 3.34 ± 0.01 min and 4.77 ± 0.01 min for Ambroxol Hydrochloride and Cefpodoxime Proxetile, respectively. The method was validated for linearity, accuracy, precision, and specificity. The method showed good linearity in the range of 30 - 60 μg/ml for Ambroxol Hydrochloride and 50 - 100 μg/ml for Cefpodoxime Proxetile. The detection limit of the proposed method was 4.56 and 12.51 μg/ml and the quantification limit was 13.82 and 37.92 μg/ml for Ambroxol Hydrochloride and Cefpodoxime Proxetile, respectively. The % recovery was within the range between 99.57% and 100.27% for Ambroxol Hydrochloride and % recovery was within the range between 99.89% and 100.86% for Cefpodoxime Proxetile. The % R.S.D for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Ambroxol Hydrochloride and Cefpodoxime Proxetile in combined tablet dosage form.