chlorpheniramine maleate, validation, cleaning, RPLC.

Producing drugs requires strict adherence to national and international standards to ensure product quality and safety. Contamination can compromise the entire production process of a drug, and cross-contamination can occur if the cleaning process fails to remove residues of previously produced drugs on the same line. To avoid such problems, tools can be employed to assist in the quality control of all processes involved in drug preparation, including equipment and utensil cleaning. This study aimed to validate an analytical method using reverse-phase liquid chromatography (RPLC) to detect and quantify the active ingredient chlorpheniramine maleate in Resfedryl® medication and to evaluate the efficiency of cleaning process in removing the drug. The method employed a Zorbax SB-CN (250 x 4.6 mm – 5 m) chromatographic column, a gradient elution in mobile phase that was composed of methanol and an aqueous solution of 0.07% (v/v) perchloric acid adjusted to pH 2.0, and a UV detector at a wavelength of 271 nm. The drug was satisfactorily eluted with a retention time of approximately 6.20 minutes. The method was found to be linear (R equal to 0.9998 and R2 equal to 0.9996), precise (%RSD between the intraday precision and the intermediate precision equal to 2,8%), accurate (recoveries between 91.48% and 94.24%), selective, relatively fast, and robust (except for the chromatographic column alteration parameter and for the solution stability parameter), with detection and quantification limits of 0.15 ppm and 0.46 ppm, respectively. The method was validated and can be applied to assess equipment and utensil cleaning quality after producing Resfedryl® medication.