Green Chromatographic Determination of Antihyperlipidemic in Their Binary Mixture, in Presence of Their Impurities and Degradation Products and Biological Fluids; Lean Six Sigma Application

Sensitive and specific green stability-indicating methods were developed for simultaneous determination of antihyperlipidemic Fenofibrate and Rosuvastatin in the binary mixture in bulk powders, tablets, in the presence of their impurities and degradation products, and human plasma by the HPLC method. The first method was based on HPTLC separation of the cited drugs from their impurities and degradation products followed by spectrodensitometric measurement of the bands at 242 nm. The separation was carried out using hexane-isopropanol-triethylamine (12:11:0.1, by volume) as a developing system. The second method was based on reversed-phase robust HPLC separation of the cited drugs from their impurities and degradation products with a mobile phase consisting of a mixture of ethanol/0.03% SDS -0.02 M citrate buffer/0.03% SDS pH 3 with citric acid gradient elution. Quantitation was achieved with UV detection at 276 nm. For the HPTLC-spectrodensitometric method the calibration curves in the range of 0.5-32 µg band-1, 0.2-13 µg band-1, for Fenofibrate and Rosuvastatin, respectively, and the HPLC method in the range of 2-32 µg mL-1 and 0.2-16 µg mL-1, for Fenofibrate and Rosuvastatin, respectively. Also, validated by Six Sigma quality using the accuracy profile for HPLC separation method, where, response surface/tolerance analysis was used.