A validated analytical method for the estimation of Oxetacaine from its pharmaceutical formulation by RP-HPLC

OBJECTIVE: The aim of the current study was to develop an analytical procedure for the determination and quantification of Oxetacaine, from its marketed formulation which is simple, precise, accurate and a validated, reverse phase high performance liquid chromatography (RP-HPLC) method. METHOD: The optimized chromatographic condition was achieved on a kromasil C18 (150 X 4.6 mm i.d., 5μ) as stationary phase and Acetonitrile: 10mM Potassium dihydrogen-ortho-phosphate (pH 3.5) in the ratio 30:70 % v/v as mobile phase, with a flow rate of 1.0 ml/min. The detector response for the method was determined, and the quantification was carried out at 214 nm. RESULT: Oxetacaine was eluted at 6.0 min. The quantification was performed using calibration curve method, and the linearity was achieved from 10-50 μg/ml. The percentage recovery was found to be 98.0 ± 1.20 respectively. The correlation coefficient was found to be 0.9954 respectively. The limit of detection (LOD) and limit of quantification (LOQ) for the current method was achieved at 1μg/mL and 5μg/mL respectively. CONCLUSION: The current study was performed at ambient temperature, and the method is simple, selective, linear, precise, accurate and sensitive which can be used for the routine analysis of Oxetacaine tablets. The developed method was validated as per ICH guidelines. ⇑ Corresponding author at: S.T. Narenderan, Department of Pharmaceutical Analysis, JSS College of Pharmacy (A Constituent College of Jagadguru Sri Shivarathreeswara University, Mysore), Udhagamandalam, India E-mail address:mail2narenderan@gmail.com INTRODUCTION Most manufacturing industries rely upon quantitative chemical analysis to ensure that the raw materials used and the final products obtained meet certain specifications in the final product. Chromatography is the method by which a mixture is separated into its individual components as a result of the relative ability of each component to be flushed along or through a stationary phase and mobile phase [1-7]. Alumina gel and magnesium hydroxide react chemically to neutralize or buffer existing quantities of acid. It has no direct effect on the production of gastric acid. Gastroscopic observations have shown that alumina gel, if taken undiluted, forms a coating over the inflamed mucosa for a variable period. Oxetacaine is a topical potent anesthetic. Combining Oxetacaine with alumina gel exerts a prolonged topical anesthetic action when applied to mucous membranes Oxetacaine chemically known as (2,2'-(2hydroxyethylimino)bis[N-(1,1-dimethyl-2-phenylethyl)-Nmethylacetamide]) is a potent safe topical anesthetic drug substance having a molecular formula of C28H41N3O3 and a molecular weight 467.64 g/mol(fig.1). Narenderan et al., August September 2017; 6(5): 2764-2768 ©SRDE Group, All Rights Reserved. Int. J. Res. Dev. Pharm. L. Sci. 2765 O