Abstract

DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF FORMOTEROL FUMARATE AND BUDESONIDE IN METERED DOSE INHALER FORMULATION

*Nanasaheb R. Kale, Dr. Ashok P. Pingle, Javed A. Mirza, Govind N. Dhongade

Abstract

A stability indicating RP-HPLC method was developed and validated for the simultaneous determination of Formoterol Fumarate (FF) 6μg and Budesonide (Bude) 400μg in metered dose inhaler formulation. The chromatographic separations was carried out with Waters alliance 2695 separation module, 2996 PDA detector and empower software and Shimadzu LC HCT 10 with UV detector and LC Solution Software instruments, using Hypersil BDS C-18, 150 x 4.6mm, 5 μ column and gradient elution with NaH2PO4.H2O buffer (pH 3.1 with OPA) and acetonitrile as mobile phase at a flow rate of 1.5 ml/min. The detection was carried out on dual wavelength detector at 214nm and 247nm for FF and Bude respectively. The detector response is linear from 0.3-0.9 μg/ml and 20-60 μg/ml concentrations for FF and Bude respectively. The linear regression equation was found to be y = 56974 x-170.74 (r² = 0.9997) for FF and y = 28487 x – 44972 (r² = 0.9994) for Bude. The stability indicating capability was established by forced degradation experiments. The method was satisfactorily validated as per the ICH guidelines.

Keywords: Formoterol Fumarate, Budesonide, HPLC, Gradient elution.