A Reversed-Phase High Performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous determination of Ambroxol Hydrochloride and Olopatadine Hydrochloride in combined tablet dosage form. The analysis was carried out using Phenomenex Luna C18, pre-packed column. Mobile phase, containing Acetonitrile: 0.05 M Potassium Dihydrogen Ortho Phosphate Buffer (70: 30) pH adjusted to 7.1 with Tri ethyl Amine was pumped at a flow rate of 1.0 ml/min with UV-detection at 248 nm. Retention time was 4.95 ± 0.007 min and 2.84 ± 0.010 min for Ambroxol Hydrochloride and Olopatadine Hydrochloride, respectively. The method was validated for linearity, accuracy, precision, and specificity. The method showed good linearity in the range of 10 – 60 μg/ml for Ambroxol Hydrochloride and 10 – 60 μg/ml for Olopatadine Hydrochloride. The detection limit of the proposed method was found to be 2.16 μg/ml and 3.26 μg/ml and the quantification limit was 6.56 μg/ml and 9.87 μg/ml for Ambroxol Hydrochloride and Olopatadine Hydrochloride, respectively. The % recovery was within the range between 98.90 - 99.93 % and 99.93 - 101.24 % for Ambroxol Hydrochloride and Olopatadine Hydrochloride, respectively. The % RSD 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 Olopatadine Hydrochloride in combined tablet dosage form.
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