Journal article Open Access

VALIDATION OF A FORCED DEGRADATION UPLC METHOD FOR ESTIMATION OF BECLOMETHASONE DIPROPIONATE IN RESPULES DOSAGE FORM

Anas Rasheed*1, Dr. Osman Ahmed2

Respules are the drugs in aqueous suspension form contained and packed in respiratory ampules, they are administered through inhalation by a device called nebulizer. The purpose of the study is to validate an UPLC method for forced degradation studies of respules which may be useful in quality control of the respiratory drugs in production for human consumption. A specific, precise, accurate and forced degradation UPLC method is validated for estimation of beclomethasone dipropionate in aqueous suspension for nebulizer. The method employed, with Hypersil BDS C18 (100 mm x 2.1 mm, 1.7 μm) column in an gradient mode, with mobile phase of Methanol, 0.1% Orthophosphoric acid and Acetonitrile in the ratio of 45:35:20 %v/v/v. The flow rate was 0.1 ml/min and effluent was monitored at 239 nm. Retention time was found to be 3.453±0.08 min. The method was validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range of 1- 10 μg/ml respectively. The LOD and LOQ values for were found to be 0.31607(μg/ml) and 0.95781(μg/ml) respectively. No chromatographic interference from respule’s excipients and degradants were found. The proposed method was successfully used for estimation of beclomethasone dipropionate in aqueous suspension for nebulizer (respules form).

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