Quantization of Dextromethorphan and Levocetirizine in Combined Dosage form Using a Novel Validated RP-HPLC Method

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Cough syrups often contain multiple active pharmaceutical ingredients.
• Accurate quantification of these ingredients is crucial for drug safety and efficacy.
• Existing analytical methods may lack efficiency or specificity for simultaneous determination.

Purpose of the Study:

• To develop and validate a simple, isocratic reversed-phase high-performance liquid chromatography (RP-HPLC) method.
• To enable the simultaneous determination of dextromethorphan hydrobromide and levocetirizine dihydrochloride in cough syrup formulations.
• To provide a rapid and reliable analytical tool for quality control.

Main Methods:

• Isocratic RP-HPLC using a C18 analytical column.
• Mobile phase: potassium dihydrogen phosphate buffer (pH 2.5) - acetonitrile - tetrahydrofuran (70:25:5, v/v/v).
• Flow rate: 1.2 ml/min; Detection wavelength: 232 nm; Run time: <10 min.

Main Results:

• Successful separation and simultaneous quantification of both active ingredients.
• High percentage recovery (approx. 100.3%) and low relative standard deviation (RSD ≤ 0.27%) for both compounds.
• Method validation according to International Council for Harmonisation (ICH) guidelines.

Conclusions:

• The developed isocratic RP-HPLC method is simple, rapid, and accurate for simultaneous determination.
• This method is suitable for routine quality control of cough syrup formulations containing dextromethorphan hydrobromide and levocetirizine dihydrochloride.
• The validated method meets regulatory requirements for pharmaceutical analysis.