High resolved stability indicting liquid chromatography method for the simultaneous quantification of Beclomethasone Dipropionate and Formoterol Fumarate dihydrate in pharmaceutical formulations
Chandana Mannepalli, M Prasada Rao, B Vijaya Lakshmi Thirupathamma, SK Shaheena Aslam, P Surendra Reddy, K Koteswara Rao
A simple, precise isocratic stability indicating RP‐HPLC method was developed for the determination of Beclomethasone and Formoterol in pure and its pharmaceutical formulations. In the developed method, Methanol and Phosphate buffer in the ratio of 85:15 (v/v) as mobile phase and Waters C-18 (250mm x 4.6mm, 5μm) column as stationary phase were used. The flow rate and detection wavelength were 1.0 mL/min and 215 nm respectively. The method was validated as per ICH guidelines for specificity, linearity and range, precision, accuracy, robustness, solution stability, limit of quantification and limit of detection. The stability-indicating capability was established by forced degradation experiments. The results of all the validation parameters were well within their acceptance limits and also the degradation products formed during the different stress conditions in stability studies were separated from both drugs and also from individual degradation products. This validated method was applied for the simultaneous estimation Beclomethasone and Formoterol in commercially available formulation sample.