SIMULTANEOUS ESTIMATION OF PARACETAMOL, GUAIPHENSIN, PHENYLEPHRINE HCl, CHLORPHENIRAMINE MALEATE AND BROMOHEXINE HCl IN COMBINED TABLET DOSAGE FORM BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATO-GRAPHY

A reverse phase high performance liquid chromatographic method was developed for the estimation of paracetamol, guaiphenesin, phenylephrine HCl, chlorpheniramine maleate and bromhexine HCL in a single tablet dosage form. This method was proved to be simple, accurate, precise and robust. The chromatographic separation was achieved on a symmetry C-8 column with dimensions of 150 X 4.6mm, 3.5µm. All the five components were separated by the gradient elution of the mobile phase A consisting of buffer 10mM KH₂P0₄   and 3.7mM of an ion pair reagent, octane-1-sulphonic acid sodium salt. The pH of the mobile phase A was adjusted to 4.0 with ortho phosphoric acid and the mobile phase B consisted of a mixture of methanol and acetonitrile in the ratio of 3:2. The wavelength of absorption was 220nm and the flow rate was fixed at 1.0 ml/min. The retention times of paracetamol, guaiphenesin, phenylephrine HCL, chlorpheniramine maleate and bromhexine HCl were found to be 5.73, 17.46, 18.29, 21.78, and 23.55 respectively. The method was validated according to the ICH guidelines for specificity, LOD, LOQ, precision, accuracy, linearity, ruggedness and robustness. The linearity range for all the drugs were performed from 10% to 150% with respect to the test concentration strength. The co-relation coefficients obtained were ≥ 0.999. The mean %recoveries for all the drugs were found to be in the range of 98 to 102%. The above validated method can be used for the analysis of combined dosage form of all these five drugs.