DEVELOPMENT AND VALIDATION OF A SIMPLE UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF FENTANYL CITRATE BOTH IN BULK AND MICRO-EMULSION FORMULATIONAbstract
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, λmax 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.
D. Mundhey *, N. Sapkal and A. Daud
Centre for Advanced Research & Innovation (CARIn), Zim Laboratories Ltd. B-21/22, Kalmeshwar, Nagpur, Maharashtra, India.
17 March 2020
18 June 2020
28 June 2020
01 March 2021