DEVELOPMENT AND VALIDATION OF DOUBLE DIVISOR RATIO SPECTRA DERIVATIVE SPECTROPHOTOMETRY METHOD FOR TERNARY MIXTURE OF DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PSEUDOEPHEDRINE HYDROCHLORIDE IN TABLET DOSAGE FORM
Objective: This study aimed to develop spectrophotometry method by double divisor ratio spectra derivative to determine the levels of dextromethorphan hydrobromide (DEX), doxylamine succinate (DOX) and pseudoephedrine hydrochloride (PSE) in tablet dosage form using ethanol as solvent.
Methods: The method is based on the use of the coincident spectra of the derivative of the ratio spectra obtained using a double divisor. Then, the method was applied to determine the levels of DEX, DOX and PSE in tablet dosage form.
Results: The application of double divisor ratio spectra derivative spectrophotometry method for the determination of DEX, DOX and PSE was performed on the first derivative at Δλ 2 (λ 277.0 nm, λ 243.0 nm, and 243.2 nm, respectively). The selection of wavelengths based on wavelengths gives the best result. The mean % recoveries were found to be in 100.88%, 100.05%, and 100.26% for DEX, DOX and PSE, respectively.
Conclusion: The method is successfully applied to analyze DEX, DOX and PSE in pharmaceutical formulation with no interference from excipients as indicated by the recovery study. All validation parameters were within the acceptable range.
Keywords: Dextromethorphan Hydrobromide, Doxylamine Succinate, Pseudoephedrine Hydrochloride, Spectrophotometry, Double Divisor Ratio Spectra Derivative
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