Quality evaluation of cephalexin 500 mg capsules

Abstract

This article contains details about the study carried out on the physicochemical quality of the 500 mg cephalexin capsules sold in Costa Rica. Cephalexin is a frequently used antibiotic that helps fight infections caused by gram-negative and gram-positive bacteria, and is in great demand because it has little toxicity and a wide therapeutic range, according to different authors. The objective of the present investigation was to determine the quality during its shelf life of cephalexin 500 mg capsules, in terms of the main evaluable physicochemical parameters. The methodology was based on conducting a random sampling at the pharmacy level in the central area of the country and acquiring the necessary number of doses (capsules) from the same batch of each of the brands that were located in said stores, to proceed to submit them. to the main quality tests in the Chemistry Laboratory of the Grecia Campus of the University of Costa Rica laboratory as established in the United States Pharmacopeia (USP 43). The tests were carried out in the Chemistry Laboratory of the Grecia Campus of the University of Costa Rica. The results show that, for the active ingredient test, the cephalexin content in the five brands considered is between 99-103% of labeling; For the dissolution test, the five brands ranged between 110-117% of dissolved active ingredient of the amount declared on the label, and in the uniformity test by weight variation, the results reflect that the acceptance value (AV) obtained ranges between 3 and 12 in the different brands. In conclusion, the compliance of the five contemplated brands was determined in terms of the established USP criteria: for the active ingredient potency test 90-120% of labeling, the dissolution test no dose is less than 85% (Q+ 5%) dissolved, and for the weight variation test the AV ≤ 15.