Quality by Design Approach for a Multicomponent Quantification Using HPLC-PDA and HPLC-MS: Application to Dosage Form and Biological Body Fluids

A multicomponent pharmaceutical that contains loratadine, paracetamol, and pseudoephedrine was quantified using HPLC-PDA. The three analytes were well-separated in the dosage form on a C-18 column gradient mobile phase. quality by design strategy followed to achieve challenging separation. Screening optimization steps carried out investigate effect of many factors studied responses with minimum number runs. ANOVA factorial model showed % acetonitrile (factor A), flow rate B), pH C) significant. detection analytes’ peaks PDA detector at 248nm for loratadine 214 nm pseudoephedrine. second method SPE-HPLC-MS, where desloratadine, active metabolite spiked plasma urine, betamethasone valerate as an internal standard. recovery from body fluids above 96%, LOQ below 0.5 ng/mL. validation developed HPLC-PDA achieved per ICH guidelines, whereas HPLC-MS validated according FDA guidelines bioanalytical validation. results compared reported method, no significant differences found.