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Original Article



Development and Validation of a Stability-Indicating RP-HPLC Method of Cholecalciferol in Bulk and Pharmaceutical Formulations: Analytical Quality by Design (AQbD) Approach

Dilipkumar Suryawanshi, Durgesh Kumar Jha, Umesh Shinde, Purnima Amin.

Abstract
The present article utilized analytical quality by design (AQbD) methodology to optimize chromatographic conditions for the routine analysis of Cholecalciferol (CHL). Taguchi orthogonal array design and Box-Behnken design were employed to screen and optimize critical method parameters for augmenting the method performance. The optimal chromatographic separation was attained on Eurosphere® 100-5, C8 (250 × 4.6 mm i.d., 5 μm) column in an isocratic elution mode using methanol: acetonitrile (50:50, % v/v) as mobile phase at a flow rate of 1.0 mL /min and Photodiode array detection at 265 nm. The optimized chromatographic method was successfully validated as per ICH Q2 (R1) guidelines. The method was found to be linear (r2 = 0.9993) in the range of 20–100 IU/mL. LOD and LOQ were found to be 10 and 20 IU/mL. The precision, robustness and ruggedness values were within the acceptance limits (RSD

Key words: Cholecalciferol, Analytical Quality by design, Taguchi orthogonal array design, Box-Behnken design, Method validation, Forced degradation studies.



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