Abstract

RP-HPLC ASSAY METHOD DEVELOPMENT AND VALIDATION OF BECLOMETHASONE DIPROPIONATE IN METERED DOSE INHALER- A RESEARCH

Sangita B. Gavitre*, Dr. Ashok P. Pingle, Nanasaheb R. Kale, Javed A. Mirza.

ABSTRACT

RP-HPLC assay method developed and validated for Beclomethasone Dipropionate in metered dose inhaler (MDI) using Testosterone propionate as an internal standard. This drug was submitted to accelerated degradation studies under acidic, alkaline and oxidation conditions, exposure to light. The separation of Beclomethasone Dipropionate was achieved on Waters Spherisorb ODS-1 column (100 x 4.6 mm, i. d. 5 μm particle size) with an isocratic mobile phase containing methanol and water (70:30, v/v). The flow rate was 2.0 mL min-1, injection volume 20μl and detection wavelength was set at 239 nm, at 50 ºC. The validation of the proposed method was carried out for specificity, linearity, accuracy, precision, and system suitability test as per ICH guideline. The retention time of Beclomethasone Dipropionate found to be 1.8 min. calibration graph was found to be linear at range 0.15- 2.25 μg/ml. The regression coefficient (r2) was found to be 0.999., the proposed method was found to be rapid and stability-indicating with adequate specificity, precision, accuracy, Ruggedness and robustness and hence be suitable for the routine analysis of Beclomethasone dipropionate in Meter dose inhalation and in bulk.

Keywords: Meter dose inhaler, international conference on harmonization, Octadesyl silane, Beclomethasone Dipropionate.