Separation and Assay of Three Anti-Cough Drugs Pseudoephedrine, Dextromethorphan and Chlorpheniramine in Pharmaceutical Forms by using single RP-HPLC Method
*Corresponding Author E-mail: firstname.lastname@example.org
The objective of this study was to develop and validate a single HPLC method, in order to separate and assay three anti-cough drugs pseudoephedrine, dextromethorphan and chlorpheniramine in pharmaceutical forms. This method was practical additional choice in quality control laboratories.
The chromatographic conditions comprised of a classical C8-type stationary phase (250 × 4.6 mm, 5μ), with a mobile phase consisting of 8.57gr/l ammonium dihydrogen phosphate, Acetonitrile, triethylamine and tetrahydrofuran (66: 30: 2: 2 v/v %) respectively, and apparent pH of 3.5 was adjusted with hydrochloric acid. The flow rate was 1ml/min; column temperature set at 30ºC; injection volume was 20μl and the detection wavelengths was at 264 nm,
The method was validated for linearity with correlation coefficients very close to one, accuracy with mean recovery values between 98.0–102.0%, precision with relative standard deviations of the calculated concentrations less than 2.0%, specificity in the presence of degradation products and robustness in the case of little change of some chromatographic conditions. Then it was used successfully to separate a mixture of them and to assay these drugs in syrup pharmaceutical form purchased from Syria. This analyzed pharmaceutical form contains three active ingredient within 100±2% of stated concentration, within the limits specified by British and USP Pharmacopeia.
The results presented in this paper showed that the developed method was simple and practical for the separation and determination of the three anti-cough drugs in syrup pharmaceutical form.
HPLC, pseudoephedrine, dextromethorphan, chlorpheniramine, method validation.