Estimation of Carbimazole in Presence of its Degradants Using RP-HPLC

RP-HPLC method has been developed and validated for the determination of carbimazole in bulk drug and marketed formulation. The developed method was found to be specific, reproducible, and stability indicating. Separation was carried out by using Inertsil, ODS-3V C18 (250 X 4.6 mm) 5μm column. Mobile phase comprising of water: acetonitrile (75:25 v/v) was used to achieve good resolution of the analyte and its impurities. The detector linearity was established in concentrations ranging from 2-10 mg mL^-1. The method was tested at different levels of specificity and accuracy as per requirements given in ICH guidelines. For stability study the drug was exposed to the stress conditions such as acid, base, oxidation, neutral and sunlight as per the recommendations of ICH guidelines. The method was proved to be robust with respect to changes in flow rate and temperature. The proposed method is found to be sensitive, precise, rapid, reproducible, and offers good column life.

Author(s): Avinash V. Deosarkar, Shruti D. Deshpande and Sanjay G. Walode

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