Contrôle de qualité de Clarithro et validation d’une méthode analytique HPLC pour Co-Expandol, deux médicaments à usage oral

Abstract

The quality of pharmaceuticals is a fundamental requirement in the pharmaceutical industry, as it directly determines both therapeutic efficacy and patient safety. This study, conducted as part of an internship at the Quality Control Laboratory of SARL BIOGALENIC, focuses on two complementary objectives: - Evaluating the quality of Clarithro 50 mg/mL, an oral suspension containing clarithromycin and which is already available on the market; - Validating a high-performance liquid chromatography (HPLC) analytical method for quality control of Co-Expandol 500 mg / 30 mg, a combination drug containing paracetamol and codeine, which is currently under development. The analyses performed on Clarithro demonstrated that the final product complies with the specifications outlined in the 8ᵗʰ edition of the European Pharmacopoeia. The results confirmed: -Compliant mass uniformity across 20 tested units; -An active ingredient content (clarithromycin) ranging between 97.5% and 106.8%, all within the acceptable range of [90 – 115%]; - Complete microbiological conformity, with no detection of E. coli, yeasts, molds, or aerobic bacteria. For Co-Expandol, the developed HPLC method was successfully validated. It demonstrated: - Excellent specificity for both paracetamol and codeine; - Outstanding repeatability with a relative standard deviation (RSD) < 2%; - Satisfactory chromatographic performance, including acceptable peak symmetry and a number of theoretical plates exceeding 1000. Collectively, these results confirm the reliability of the analytical methods, the compliance of the analyzed batches, and the effective control of manufacturing processes within the company. This work highlights the crucial role of quality control and analytical validation throughout the pharmaceutical product life cycle, ensuring safety, efficacy, and compliance with regulatory requirements.