Development and Validation of a Simple Liquid Chromatography Method for the Quantification of Degradation Products of Beclomethasone Dipropionate from a Respirator Suspension Formulation

Author(s)

Vaidya, V. V., Phatak, M. S., Gomes, A. D.

Author's Affiliation

Abstract

Beclomethasone dipropionate is a corticosteroid used extensively for the treatment of allergic rhinitis and asthma. Being a steroid prepared synthetically, it has quite a few known related substances and degradation products which are structurally similar to Beclomethasone. Pharmacopeial methods available for the determination of the impurities of Beclomethasone dipropionate utilize harsh conditions and a long analytical run time. In the present work a simple method has been developed for the quantification of the process impurities and the degradation products of Beclomethasone dipropionate from a respirator suspension formulation. The separation has been achieved using an ultra-performance liquid chromatographic method. The method utilizes a Waters Acquity BEH C18 UPLC column using gradient elution with mobile phase consisting of acetonitrile and distilled water. The separation of 10 known process impurities and degradation products was achieved in about 20 minutes. The method was found to be sensitive, selective, precise, accurate and robust under the conditions tested. The method was utilised for the stability monitoring of the respirator suspension formulation and was found to provide accurate and consistent results.

Keywords

Beclomethasone, Degradation, Respirator Formulation

Cite This Article

Vaidya, V. V., Phatak, M. S., & Gomes, A. D. (2014). Development and Validation of a Simple Liquid Chromatography Method for the Quantification of Degradation Products of Beclomethasone Dipropionate from a Respirator Suspension Formulation. International Journal for Pharmaceutical Research Scholars (IJPRS), 3(4), 10-16.