Development, Determination and Validation RP-HPLC Method Lab Routine for an Active Pharmaceutical Ingredient: Chlorpheniraminemaleate, Acetaminophen and Pseudoephedrine Hydrochloride, Simultaneous in Some Local Cold-Flu Tablets Formulation


  • Mahmood. SH. Mahmood, EmanThiab Al Samarrai


A new simple analytical method was developed using the high-performance liquid chromatography reverse-phase technique, and simultaneous separation method, to estimate of Cold-Flu drugs,containing medicinally active substances Chlorpheniramine Maleate,Acetominophene, pseudoephedrine hydrochloride, in its pharmaceutical forms as tablets.The separation carried out using an isocratic separation method concerning the mobile phase, as it consisted of a mixture of 1-Pentanesulfonic acid sodium dissolved in water with a concentration of 0.01 M  with acetonitrile 22/78, respectively, and pH=3 adjusted. It was using a C8 column (4.6 x 250 mm 5?m) separation with a flow rate of 1 ml/ minute and at a total retention time not to exceed 6 minutes at a temperature of 30 C°. Ultra-violet spectroscopy (UV)performed on the active ingredients of the Cold-Flu drug, where a uniform wavelength of 210 nm was adopted at the absorption peaks of all of them using the mobile phase as a solvent. The linearity study of the area under the peak (AUP) versus concentration method performed within the range of Chlorpheniramine maleate(4-32)10-3, Acetominophen(25-80)10-3,  Pseudoephedrine hydrochloride(15-48)10-3, and the correction coefficient not less than 0.9994 with Relative standard deviation (RSD%) 1.04% maximum. The success achieved in reaching the purpose of the method, where the data showed that the study method is accurate, reproducible, and suitable for the laboratory routine.

Keywords: Analytical method, HPLC, Chlorpheniramine maleate, Acetominophen,  Pseudoephedrine hydrochloride, ICH.