STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF SUCRALFATE AND OXETACAINE IN BULK AND MARKETED FORMULATION BY RP-HPLC

The objective of present study is to develop and validate a method for the estimation of sucralfate and oxetacaine in suspension dosage form. An isocratic reversed phase high performance liquid chromatographic method was developed to estimate sucralfate and oxetacaine using thermohypersil BDS (4.6 x 150mm, 5). The mobile phase was prepared by mixing ammonium acetate (pH- 4.4) and methanol in the ratio of (60:40 v/v) which is run isocratically at the flow rate of 0.8ml/min. the wavelength at which detector (PDA) was set is 263nm. The retention time of oxetacaine and sucralfate is 2.08 and 3.4 minutes. Linearity was observed in the concentration range of 20-60g/ml for oxetacaine and 1000-3000g/ml for sucralfate. The percent recovery of sucralfate and oxetacaine was found to be 100. The limit of detection of oxetacaine and sucralfate is 0.178 g/ml and 2.93 g/ml and the limit of quantification of oxetacaine and sucralfate is 0.541 g/ml and 8.879 g/ml. The formulation was subjected to acid, base, peroxide, sunlight and heat and stressed samples were analysed by proposed method. The results confirmed that the proposed method is specific, rapid, reproducible and suitable for the routine determination of sucralfate and oxetacaine.