Transfert De La Methode De Dosage De La terbutaline Sulfate En Solution injectable

Abstract

Transfer of the analytical method for injectable terbutaline sulfate: application and statistical approach. UV-visible spectrophotometry is an analytical technique widely used, particularly in the pharmaceutical industry, where it plays an essential role in drug quality control. Analytical method transfer is of paramount importance in this context, as it ensures that results produced by a receiving laboratory are reliable, reproducible, and equivalent to those of the originating laboratory. The objective of this work is to transfer a validated quantification method for injectable terbutaline sulfate by UV-visible spectrophotometry, using rigorous statistical approaches in accordance with the methodological recommendations of Rozet et al. and applicable regulatory frameworks (ISPE, WHO, USP <1224>). The method is based on the quantification of injectable terbutaline sulfate 0.5 mg/mL in basic medium (NaOH 0.1 M) at an optimal wavelength (λmax) = 296 nm, within a concentration range of 80% to 120% (i.e., 0.04 mg/mL to 0.06 mg/mL). Three series of triplicate measurements were performed in both the sending and receiving laboratories. The statistical evaluation of the transfer focused on trueness and intermediate precision, using two complementary approaches. The descriptive approach revealed a relative bias of 0.787%, well below the acceptance limit of ±5%. The equivalence approach yielded a 90% confidence interval for the bias entirely included within the decision interval [-10%; +10%]. Regarding precision, the intermediate precision coefficient of variation for the receiving laboratory (RSDIP = 3.252%) remained below the 5% limit, and the upper one-sided 95% confidence limit (LU= 1.643%) stayed well within the 10% threshold. In accordance with regulatory requirements, this analytical transfer is accurate, precise, and statistically equivalent; the UV-visible spectrophotometric method for the quantification of terbutaline sulfate is therefore successfully transferred to the receiving laboratory