ANALYTICAL STABILITY INDICATING UPLC ASSAY AND VALIDATION OF CICLESONIDE IN DRY POWDER INHALER DOSAGE FORM

Anas Rasheed* and Dr. Osman Ahmed

ABSTRACT

A selective, precise, accurate and stability indicating UPLC method is validated for estimation of Ciclesonide in dry powder inhaler dosage form. The method employed, with Hypersil BDS C18 (100 mm x 2.1 mm, 1.7 μm) column in gradient mode, with mobile phase of Methanol and Acetonitrile in the ratio of 55:45 %v/v. The flow rate was 1.2 ml/min and effluent was monitored at 240nm. Retention time was found to be 7.335±0.005 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 8- 40μg/ml respectively. The LOD and LOQ values for were found to be 0.83836 (μg/ml) and 2.54048 (μg/ml) respectively. No chromatographic interference from dry powder inhaler’s excipients and degradants were found. The proposed method was successfully used for estimation of Ciclesonide in dry powder inhaler dosage form.

Keywords: Ciclesonide, UPLC, Validation, dry powder inhaler, stability indicating method.