Short communicationQuality by design (QbD) based development and validation of an HPLC method for Amiodarone hydrochloride (cas 19774-82-4) and its impurities in the drug substance

Add time:09/08/2019    Source:sciencedirect.com

The USP monograph describes an HPLC method for seven impurities in the amiodarone drug substance using a L1 column, 4.6 mm × 150 mm, 5 μm packing (PF listed ODS2 GL-Science, Inertsil column) at 30 °C with detection at 240 nm. The standard contains 0.01 mg/mL of amiodarone, and USP specified impurities D and E with a resolution requirement of NLT 3.5 between peaks D and E. Impurities in a 5 mg/mL sample are quantitated against the standard. Impurity A peak elutes just before peak D. We observed two problems with the method; the column lot-to-lot variability resulted in unresolved A, D, and E peaks, and peak D in the sample preparation eluted much later than that in the standard solution. Therefore, optimization experiments were conducted on the USP method following the QbD approach with Fusion AE™ software (S-Matrix Corporation). The resulting optimized conditions were within the allowable changes per USP 〈621〉. Lot-to-lot variability was negligible with the Atlantis T3 (Waters Corporation) L1 column. Peak D retention time remained constant from standard to sample. The optimized method was validated in terms of accuracy, precision, linearity, range, LOQ/LOD, specificity, robustness, equivalency to the USP method, and solution stability. The QbD based development helped in generating a design space and operating space with knowledge of all method performance characteristics and limitations and successful method robustness within the operating space.

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