Quality by Design Approach for Development and Validation of a RP-HPLC Method for Simultaneous Determination of Xipamide and Valsartan in Human Plasma

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Abstract A new rapid, simple and sensitive RP-HPLC method was developed through employing Quality by Design (QbD) approach for determination xipamide and valsartan in Human plasma. Fractional factorial design (FFD) was applied for screening of the four independent factors: pH, flow rate, detection wavelength, and % of MeOH. Analysis of variance (ANOVA) confirmed that flow rate and % of MeOH were only significant. The optimization of the chromatographic conditions was carried out through using central composite design (CCD). Method Analysis was achieved using BDS Hypersil C8 (250 × 4.6 mm, 5 µm) column and an isocratic mobile phase of MeOH and 0.05M KH2PO4 buffer pH 3 (64.5:35.5, v/v) at 1.2 mL/min flow rate with UV detection at 240nm and 10 µL injection volume. According to FDA guidelines, the method was then validated for the determination of the two drugs clinically in human plasma in respect of future pharmacokinetic and bioequivalence simulation studies. The standard curve was linear in the concentration range of 5-100 µg/mL for both drugs, with a correlation coefficients (R2) of 0.999. The average recoveries ranged from 99.89 to 100.03%. The proposed method showed good predictability and robustness.

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