Evaluation of some quality parameters of five brands of Cetirizine hydrochloride tablets marketed in Abuja, Nigeria.

Abstract

Cetirizine Hydrochloride is a non-drowsy second-generation antihistamine and a derivative of piperazine with a half-life of eleven hours. It is used to relieve allergy symptoms such as runny nose, sneezing, rhinitis, urticaria and watery eyes. It is a key adjuvant therapy in management of some covid-19 related symptoms. To assess the quality of five brands of Cetirizine hydrochloride 10mg tablets marketed in Abuja. The weight variation, friability, hardness, disintegration, dissolution tests and HPLC assay were evaluated using USP methods. The hardness and friability of the samples ranged from 2.03kgF to 7.54KgF and 0.00 to 0.90% respectively. The disintegration time were within 5mins, for dissolution, 80.0 to 103.3% of the API in the samples were released within 30mins, the assay ranged from 93.1 to 101.6%. The cetirizine tablets conformed with quality standards.

Application of ISO 17025 Standards in the Validation of a Spectrophotometric Method for Quality Assessment of Generic Brands of Cetirizine Tablets marketed in Nigeria.

“…That was not the case in our study as the friability values of all the samples were less than 1.0 % which is the acceptance limit according to the USP standard. Previous quality tests on CTZ also met the 18,19,20,21 official specifications. The friability test measures the tablet's resistance to abrasion or fracture.…”

“…The adopted and validated method was used in the determination of the content of CTZ in the nine commercial brands of CTZ tablets (10 mg). Twenty (20) tablets from each sample were weighed and crushed to a fine powder in a clean porcelain pestle and mortar. An amount of the finely powdered sample equivalent to one tablet (10 mg) of CTZ was weighed and transferred into a clean 500 mL volumetric flask and dissolved with approximately 250 mL matrix solution.…”