Quality by design (QbD) based development and validation of an HPLC method for amiodarone hydrochloride and its impurities in the drug substance

- There were performance issues with the USP HPLC method for amiodarone impurities.
- The USP method was successfully optimized using QbD approach.
- The method was successfully validated per ICH Q2R.
- The optimized method is equivalent to the USP method.
- The method is routinely used for determining amiodarone impurities.