Abstract

ESTIMATION OF FLUTICASONE PROPIONATE IN NASAL PREPARATION AND IN COMBINATION WITH FORMOTEROL FUMARATE IN INHALATION PREPARATION

Priyank P. Raval*, Dr. J. B. Dave , Mittal P. Joshi, and Bhargav K. Solanki

ABSTRACT

The Reversed Phase Ion Pair HPLC method has been developed and validated for the estimation of Fluticasone propionate in nasal preparation and in combination with Formoterol fumarate in DPI (Dry Powder Inhalation). This method was developed using ACE C18 Column (150 mm×4.6 mm id, 5μm) and Acetonitrile: 10mM Sodium di-hydrogen ortho phosphate buffer containing 10 mM Decane sulphonic acid sodium salt (50:50 v/v) as the mobile phase at 1ml/min flow rate with detection at 220nm.Decane sulphonic acid sodium salt proved to be better than other anionic ion pairing agents. This method was validated as per ICH guideline. The method was linear in the concentration of 1.5-12 μg/mL for Formoterol and 25-200 μg/mL for Fluticasone with a correlation coefficient of 0.999 each. The LOQ for Formoterol and Fluticasone was 0.0244μg/ml and 0.7445μg/ml respectively. The method successfully separated both the drugs from potential degradation products in stress samples with adequate peak purity establishing specificity and stability indicating nature of the method. Both the drugs degraded under photolytic condition; but Fluticasone degraded more and yielded there degradation peaks which further increased in presence of Formoterol. Both the drugs did not show degradation under thermal, thermal-humidity conditions. Fluticasone was more susceptible to alkaline hydrolysis giving two degradation peaks as compared to acidic hydrolysis when yielded one degradation peak. All method validation parameters were within the acceptance criteria as per ICH guideline. The method is deemed to be stability indicating as it separates both the drugs from likely degradation products.

Keywords: Formoterol fumarate, Fluticasone propionate, Dry Powder Inhalation, Nasal spray, Forced degradation study