OPTIMIZED METHOD FOR RAPID ESTIMATION OF CICLESONIDE IN BULK AND ITS DOSAGE FORM (ROTACAP) BY RP-HPLC

Abstract

Ciclesonide, 2-[(1S,2S,4 R,8S,9S,11S,12S,13 R)-6-cyclohexyl-11-hydroxy-9,13-dimethyl-16-oxo-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-8-yl]-2-oxoethyl 2-methyl propanoate, persists as a newer anti-asthmatic drug of the glucocorticoid class. A fast, safe, and sensitive method for estimation of Ciclesonide was developed as it is officially in IP-2007 and acquires a longer time for detection. The chromatographic separation employs isocratic elution by utilizing an inertsil ODS-C18, 250 mm × 4.6 mm, 5 µm columns. A mobile phase consisting of solvent [solution containing Methanol:Water (95:05%, v/v)] endowed at a flow rate of 1.0 mL min⁻¹. The analyte was detected and quantified at λ_max 242 nm using UV detector. The method was validated according to ICH guidelines, illustrating to be accurate (98.91%–100.59%) and precise (CV = 0.21–1.11 for intra-day and CV = 0.21–1.51 for inter-day) within the corresponding linear range.

Keywords:

• anti-asthmatic
• ciclesonide
• glucocorticoids
• RP-HPLC

ACKNOWLEDGMENT

The authors are grateful to Zydus Cadila Pharmaceutical (Sakhej-Bavla Highway, Moraiya, Ahmedabad), for supplying Ciclesonide as a gift sample and to the Department of Pharmaceutical Chemistry, A.R. College of Pharmacy and Institute of Science and Technologies for Advanced Studies and Research, Vallabh Vidyanagar, for providing facilities to carry out the work.

Notes

Formulation 1 is Ciclohale 0.2 mg; Cipla, Goa.

*Six replicate samples.

^a Average of three determinations.

^b Recovery of amount added to the pharmaceutical formulation (average of three determinations).

*At 95% confidence interval, (t-Tabulated = 4.30).

^a Means Y = bX + c, where X is concentration in µg/mL and Y is absorbance unit.

^b Means six replicate samples.