Validation de la méthode de dosage de la terbutaline injectable : application et démarches statistiques

Abstract

UV-visible spectrophotometry is an analytical technique widely used, particularly in the pharmaceutical industry, where it plays an essential role in drug quality control. The validation of this type of analytical method is of paramount importance as it guarantees the reliability and accuracy of the obtained results. The objective of this work is to validate a simple method for the quantification of injectable Terbutaline by UV-visible spectrophotometry, in accordance with ICH Q2 (R1) guidelines and the European pharmacopoeia. The proposed method is based on the quantification of terbutaline sulfate injectable 0.5 mg/mL in basic medium at a wavelength (λmax) = 296 nm which was validated in a range (80% -120%) thus (0.4 mg/mL-0.6mg/mL). After performing an appropriate specificity study, the linearity study gave an R² of 99.59%, R of 99.79% and a slope significantly different from 0. An average recovery percentage of 99.886% with CI ± 5%. The method's repeatability demonstrated intra-day RSD (1.46%) and inter-day RSD (1.92%) being below 2%. In accordance with ICH Q2 (R1) requirements, this method is specific, linear, accurate and precise and is therefore validated for the quality control of Terbutaline in injectable solution.