QbD and Six Sigma quality approach for chromatographic estimation of repurposed simvastatin from nanostructured lipid carriers

Popat Kumbhar,Pramod Waghmare,Sameer Nadaf,Arehalli Manjappa,Rohit Shah,John Disouza

Microchemical Journal（2023）

引用 3|浏览10

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摘要

•QbD and Six Sigma quality approach for chromatographic simvastatin (SMV) estimation.•RP-HPLC method was validated according to ICH Q2 (R1) guidelines.•The proposed method is statistically controlled, simple, robust, rapid and economic.•This validated method can also be used to estimate SMV in other lipidic nanosystems.•This method will be thrust into the limelight to appease analytical chemists.

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关键词

Simvastatin,Nanostructured lipid carriers,Drug repurposing,Quality control,Validation,Statistical analysis

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