Abstract

A RAPID AND STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF TIOTROPIUM, FORMOTEROL AND CICLESONIDE IN A DRY POWDER INHALER

Sunita Sule, Sushama Ambadekar, Abhay Singh, Phalguni Naik

Abstract

A stability indicating reversed phase high performance liquid chromatographic method has been developed and validated for simultaneous assay of Tiotropium, Formoterol and Ciclesonide from a dry powder inhalation formulation. Separation was achieved on a C18, 5μm x 250 mm column at 40°C temperature using Acetonitrile as organic modifier; Disodium hydrogen phosphate anhydrous as buffer and Decane sulfonic acid sodium salt as the ion pairing agent at pH 3.5 and UV detection at 230 nm. Forced degradation studies was performed and the method could effectively separate the interferences from placebo, primary packaging material, impurities and degradants, hence the method is specific and stability indicating method. The method was validated in line with the ICH guidelines in terms of linearity, precision, accuracy, specificity, robustness and solution stability.

Keywords: Dry powder inhaler, Tiotropium Bromide monohydrate, Formoterol Fumarate dihyrdate, Ciclesonide, HPLC, Assay and Validation.