HPLC Method Development and Validation for Simultaneous Estimation of Succinic Acid and Succinylmonocholine in Succinylcholine Chloride Injection

Abstract

Succinylcholine chloride injection USP is a sterile, non-pyrogenic solution to be used as a short-acting, depolarizing, skeletal muscle relaxant. The injection is administered as IM or IV use. Succinylcholine chloride, USP is chemically designated C14H30N2O4 and its molecular weight is 290.399. Succinylcholine chloride has three known impurities: (1) Doublet peak, (2) Succinic acid and (3) Succinylmonocholine chloride. Out of these impurities, succinic acid and succinylmonocholine chloride are degradation impurities, whereas doublet peak is process related impurity. These impurities are controlled in succinylcholine chloride injection. Hence, an analytical method for simultaneous estimation of succinic acid and succinylmonocholine chloride in succinylcholine chloride injection is developed and validated. In this method, succinic acid and succinylmonocholine chloride were found to be specific, linear and robust. The method is also stability indicating as evidenced by forced degradation studies. Hence, this method can be used for routine analysis.

Keywords: Succinylcholine chloride injection, degradation products, HPLC

Cite this Article

Subrahmanya Bhat K, Puranik SB, Mahabaleshwara K. HPLC method development and validation for simultaneous estimation of succinic acid and succinylmonocholine in succinylcholine chloride injection. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2015; 2(3): 52–60p