Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ACETAMENOPHEN DEXTROMETHORPHAN HYDRO BROMIDE DOXYLAMINE SUCCINATE IN SOFT GEL CAPSULE DOSAGE FORM BY USING RP-HPLC

Alagar Raja*.M, Samatha.M, David Banji, Rao.K.N.V, Sujitha, Vinod.J,Selva Kumar.D

ABSTRACT

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 Waters C18 column (250x4.6mm,5μm particle size) ,and the mobile phase used as 6.8gm of potassium dihydrogen phosphate buffer of pH adjusted to 3.5 ± 0.05 with o-phosphoric acid(A) and Acetonitrile (B). A: B ratio was 85:15v/v for the initial 15.0 min, and then it was maintained at 70:30v/v for the next ten minutes and finally for the last ten minutes it was maintained at 85:15v/v; the flow rate is 1.2 ml/min. The column temperature is set at ambient temperature and wavelength fixed at 270nm UV-detection. The described method of Acetaminophen linear over a range of 162.5μg/ml to 487.5μg/ml and Dextromethorphan hydro bromide range of 5-15μg/ml and Doxylamine succinate in range of 3.125-9.375μg/ml. The method precision for the determination of assay was below 2.0%RSD. The percentage recoveries of active pharmaceutical ingredient (API) from dosage forms ranged from 98%-102%. The method is useful in the quality control of pharmaceutical formulations. This provides a complete separation and determination of Acetaminophen, Dextromethorphan hydrobromide and Doxylamine succinate .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. And validation study compared as per ICH guideline.

Keywords: HPLC, Acetaminophen, Dextromethorphan hydrobromide and Doxylamine succinate.