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Abstract

SIMULTANEOUS DETERMINATION OF BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE IN ROTACAP DOSAGE FORM USING TWO DIFFERENT SPECTROPHOTOMETRIC METHODS

Parth D. Shah*, Dr. ShaileshKoradia

ABSTRACT

Two simple, rapid and precise UV spectroscopic methods namely Simultaneous equation (method 1), Q-absorbance ratio (method 2) and have been developed for the simultaneous determination of Beclomethasone dipropionate and Formoterol fumarate. In method 1, both the drugs exhibit good linearity over the concentration range of 10-50μg/ml and 1 to 5μg/ml of BD and FF at 239.2nm (r2=0.998 and 0.998 respectively) and 213nm (r2=0.999 and 0.998 respectively) wavelengths respectively. Method 2 involves the formation of Qabsorbance equation using the absorptivity values at 218.3 nm (isoabsorptive point) (r2=0.998 and 0.998 respectively) and 239.2nm (λmax of BD)(r2=0.998 and 0.999 respectively) and Beer’s Lambert’s law was obeyed over the concentration range of 10-50μg/ml and 1-5μg/ml respectively. The proposed methods were validated according to ICH guidelines for evaluation of accuracy, precision, sensitivity etc. In conclusion, the proposed methods are novel, simple, accurate, precise, sensitive, rapid and economically viable methods that do not require any prior separation procedure. The proposed two methods hold potential for simultaneous determination of BD and FF in rotacap formulation.

Keywords: Beclomethasonedipropionate, Formoterolfumarate, Spectrophotometric method, Simultaneous equation method, Q-ratio method, Validation.


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