Abstract
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.
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