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ISSN 2063-5346
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DEVELOPMENT AND VALIDATION OF RPHPLC METHOD FOR ASSAY OF FLUTICASONE FUROATE FROM NASAL SPRAY FORMULATION

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Vitthal Chopade1* , Vishnu Neharkar2 , Padmanabh Deshpande3 , Makarand Puri4 , Priti Khanapure1 , Vaishnavi Chopade5 , Minal Ghante6 , Jayshree Jagtap7 , Shital Godse6 , Vidhya Bhusari6 , Vasundhara Sawant6 , Sonali Labhade8 , Rajendra Kawade9 , Deepali Kadam10, Nilesh Jadhav11, Gaffar Sayyad12, Dipti Phadtare13 , Shital Godse6 , Pandurang Vijapure14, Kunal Survade13, Rahul Mohan9 , Arvind Hatkar9 , Atul Baravkar15
» doi: 10.31838/ecb/2023.12.s1-B.256

Abstract

The literature search reveals that, several HPLC methods for the determination of Fluticasone furoate in combination with other drugs are reported with long run time, high solvent consumption or with less available instrument as compared with HPLC. There is no any reported HPLC method for individual assay of Fluticasone furoate from nasal spray formulation. So the purpose of present experimental work is to develop a rapid, simple, precise, accurate, specific, and sensitive high performance liquid chromatographic method for assay of Fluticasone furoate from nasal spray formulation. The desired chromatographic separation was achieved on the Inertsil ODS-3V 250 x 4.6 mm, 5µ column, using isocratic elution at 240 nm wavelength. The optimized mobile phase constituted of purified water and acetonitrile in the ratio of 20:80 % v/v delivered at the flow rate 1 ml/min with isocratic elution. The retention time of fluticasone furoate was 5 min. The method was validated according to International conference of harmonization guidelines in terms of accuracy, precision, specificity, robustness, linearity and other aspects of analytical validation. Linearity was established in the concentration range of 27.5 to 82.5 ppm (r2=1.000). The recoveries obtained were 99.4 -100.5 %. Similarly the % RSD value for precision was also found to be within the acceptable limit. Developed method was simple and convenient which could be successfully applied for the routine analysis.

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