ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF FLUNISOLIDE IN NASAL SPRAY FORMULATION BY RP-HPLC

摘要

Objective: The objective of the present research work was to develop and validate reversed-phase high-performance liquid chromatography (RP-HPLC) method for quantification of flunisolide in nasal spray formulations. Methods: The developed method was validated according to International Conference on Harmonisation (ICH) guideline with respect to system suitability, accuracy, precision, specificity, linearity, and robustness. An isocratic condition of mobile phase comprising phosphate buffer (pH 5.5): acetonitrile: tetrahydrofuran in a ratio of 73:15:12, v/v at a flow rate of 1.0 ml/minute over RP C18 (octadecylsilane (ODS), 150 × 4.6 mm, 5 μm, Phenomenex Inc.) column at ambient temperature was maintained. Results: The method showed excellent linear response with correlation coefficient (R 2 ) values of 0.999, which was within the limit of correlation coefficient (R 2 ≥ 0.995). Intra and inter-day precision studies of the new method were less than the maximum allowable limit percentage of relative standard deviation %RSD ≤ 2.0. Conclusion: A simple reversed-phase HPLC method for the analysis of flunisolide in nasal spray formulations was developed and validated. Keywords: Flunisolide, ICH, Nasal Spray, RP-HPLC, Validation