RP- HPLC Method Development and Validation for Simultaneous Estimation of Ambroxol Hydrochloride and Cefpodoxime Proxetile in Pharmaceutical Dosage form

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.