A new, simple, precise, and accurate reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the simultaneous determination of Ambroxol Hydrochloride and Doxofylline in pharmaceutical dosage forms. Separation was carried out on Perkin Elmer HPLC system equipped Perkin Elmer LC- C18 column (250 X 4.6 mm, I.D. 5 μ) using Acetonitrile: Methanol: 20 mM Ammonium acetate buffer (pH 6.4) (30:45:25 v/v/v) as the mobile phase. The flow rate was adjusted to 1.0 ml/min with UV detection at 254 nm. The retention times of Ambroxol hydrochloride and Doxofylline were found to be 5.25±0.011 min and 2.90±0.01 min respectively. The different analytical parameters such as accuracy, linearity, precision, robustness, limit of detection (LOD), and limit of quantitation (LOQ) were determined according to the International Conference on Harmonization (ICH) guidelines. The detector response was linear in the range of 1.0 to 4.0 μg/ml and 13.0 to 52.0 μg/ml for Ambroxol hydrochloride and Doxofylline respectively. The percentage recovery of Ambroxol hydrochloride and Doxofylline were obtained from the range of 99.24-100.7 % and 99.57-100.13% respectively. The % R.S.D. values for intra-day and inter-day precision study were <2.0%, confirming that the method was sufficiently precise. The method can be successfully applied for the simultaneous analysis of both drugs in tablet dosage forms and statistical analysis of the data revealed that the method is precise, accurate, reproducible, sensitive and suitable for the routine quality control analysis.
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