Related Substances of Acetaminophen In Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate Soft Gelatin Capsules by Using RP-HPLC Method

The analysis of improved HPLC-UV detector method for the separation and quantification of Acetaminophen, Dextromethorphan hydrobromide and Doxylamine succinate is described. Samples are analysed by means of reverse phase (RP-HPLC) using a Zodiac C-18, (250 × 4.6 mm, 5 µ), and the mobile phase consists of two Channels A and B. Channel-A pH 6.0 Buffer: Methanol (85:15) and Channel-B pH 3.0 Buffer: Acetonitrile (70:30). The flow rate is 1.0 ml/min. The column temperature was maintained at 30˚C and sample temperature was maintained at ambient and wavelength fixed at 245nm UV-detection. It is found that the method of RP-HPLC with UV-detection system for the analysis of Acetaminophen, Dextromethorphan hydrobromide and Doxylamine succinate is straight forward and applied in qualitative and quantitative analysis. The developed LC method was validated with respect to specificity, precision, linearity, ruggedness, stability of analytical solution and robustness. Validation study compared as per ICH guideline.