Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FORMOTEROL FUMARATE AND BUDESONIDE IN PRESSURISED METER DOSE INHALER FORM BY USING RP-HPLC

P. S. Raghu*

ABSTRACT

A reversed-phase-liquid chromatographic (RP-HPLC) method was developed for the simultaneous estimation of formoterol fumarate and budesonide in pressurised meter dose inhaler form. The method was carried out on a thermo hypersil C-18 column (250 mm × 4.60 mm i.d., particle size 5 μ m), with a mobile phase consisting of Methanol: buffer phosphate 40:60 v/v adjust the pH 3.6at flow rate 0.5 ml/ min. The wavelength used for detection of formoterol fumarate and budesonide was 267 nm. The retention time of formoterol fumarate and budesonide were found to be 6. 6 8 ±0.10 min. and 5.84 ±0.10 min. res pectively. The method was validated in terms of linearity, range, accuracy, and precision, limit of detection (LOD) and limit of quantitation (LOQ) as per ICH guidelines. The method showed a good linearity in the concentration range of 17.5-52.5 μ g/ml for Formoterol fumarate and for Budesonide 6-18 μ g/ml. The % recoveries of Formoterol fumarate and Budesonide were found to be between 99.90-100.56% and 99.75-100.63% respectively. The %RSD for the method precision was found to be less than 2%.The proposed method can be successfully applied for the simultaneous estimation of Formoterol fumarate and Budesonide in combined tablet dosage form.

Keywords: Formoterol fumarate, Budesonide RP-HPLC, Pressurised Metered Dose Inhaler, Author mail.


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