DEVELOPMENT AND VALIDATION OF AN ANALYTICAL METHOD TO DETERMINE DEGRADATION PRODUCTS IN MEPIVACAINE 3%

Abstract

Mepivacaine 3% injectable solution is an amide-type local anesthetic that in dentistry is indicated for local anesthesia by infiltration or nerve block of the entire oral cavity and as an anesthetic in the upper and lower jaw. Like all local anesthetics, Mepivacaine blocks the initiation and production of nerve impulses by decreasing the permeability of the neuronal membrane to sodium ions, thereby reversibly stabilizing the membrane. The UEB Laboratorios Liorad is in charge of producing this drug and the Development and Innovation Unit (UDI) is responsible for carrying out the stability studies; both belonging to the AICA+ Company. The Cuban biopharmaceutical industry works in the manufacture of products that allow satisfying the needs of the National Health System and currently all national and international drug regulatory institutions require the presentation of results of degradation products in stability studies for the finished formulations. In order to comply with the established regulations, we set out to develop a method described in the British Pharmacopoeia (BP 2015), of Related Substances for the active pharmaceutical ingredient of Mepivacaine Hydrochloride and validate it qualitatively in the finished product. The validation of the analytical method was carried out by evaluating the parameters of specificity and limit of detection. The results demonstrated the specificity of the method by not observing interference from the excipients of the formulation.