Abstract

DEVELOPMENT OF VALIDATED STABILITY INDICATING HPTLC METHOD FOR LIGNOCAINE HYDROCHLORIDE AND ITS APPLICATION TO THE ASSAY OF FORMULATION AND DEGRADATION KINETICS

A. Suganthi*, Sruthi Vinod, K. Arthi and T. K. Ravi

ABSTRACT

HPTLC method was developed for lignocaine hydrochloride on silica gel 60 F254 TLC plates using mobile phase comprising of toluene:methanol:ethylacetate ( 6:2:2%v/v/v) with two drops of ammonia and the detection was carried out at 270 nm using densitometer. The Rf value of lignocaine hydrochloride was 0.68± 0.02. The percentage recovery of the drug from injection formulation was carried out by standard addition method and was found to be close to 100 and %RSD less than 2% indicated good accuracy and precision of the method. The drug was subjected to acid, alkali and neutral hydrolysis, oxidation, thermal and photolytic degradation. The degradation study indicated lignocaine hydrochloride to be susceptible to acid hydrolysis and hydrogen peroxide. The degradation product was well resolved from the pure drug with significant differences in Rf values. The developed validated method was applied to formulation and degradation kinetics of lignocaine hydrochloride. The rate of hydrolysis was found to increase with increase in the strength of hydrochloric acid. It was observed that the temperature had a major effect over acid hydrolysis of lignocaine hydrochloride compared with varying strength of hydrochloric acid. Further this study can be extended for the determination of shelf life of formulation containing lignocaine hydrochloride.

Keywords: Lignocaine hydrochloride, HPTLC, stability indicating, degradation kinetics. WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES SJIF Impact Factor 5.210 Volume 5, Issue 1, 661-671 Research Article ISSN 2278 – 4357 Article Received on 24 Oct 2015, Revis