DEVELOPMENT AND VALIDATION OF A SIMPLE UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF FENTANYL CITRATE BOTH IN BULK AND MICRO-EMULSION FORMULATION

摘要

Objective: Development of simple, rapid, and accurate UV spectrophotometric method for the estimation of Fentanyl citrate (FC) in a bulk and pharmaceutical dosage form. The proposed method was validated according to the guidelines of the International Conference on Harmonization and the Association of Official Analytical Chemists International. Methods: The method was based on the measurement of absorbance at a wavelength of257.6 nm, λ max of FC in methanol, respectively. Results: The calibration curve of FC was linear in the concentration range of 200-1400 μg ml -1 . The mean recovery, the limit of quantification (LOQ) and limit of detection (LOD) for FC were 99.029%, 1.031 μg ml-1and 0.340 μg ml -1 , respectively. The method was precise, with a relative standard deviation of less than 2.0 %. For robustness, the factors analyzed did not significantly affect the quantification of FC. Conclusion: The proposed method can be successfully applied for the estimation of FC in a bulk and pharmaceutical dosage form.