Abstract
Analytical quality by design (AQbD) based high performance liquid chromatographic (HPLC) method for routine analysis of acyclovir and hydrocortisone in dosage form has been developed on C18 column using experimental design. Central composite design (CCD) was adopted in assessment of method responses and robustness. In experimental design, resolution (Y1) and separation factor (Y2) were tested method critical parameters such as pH (X1), % aqueous in mobile phase (X2) and flow rate (X3). Two models for retention time (Y1) and separation factor (Y2) were obtained and then interpreted statistically. Chromatographic optimum range for each input variable (Xn) was obtained through analysis of constructed models and contour plots. The predicted data from response models for resolution time (Y1) and separation factor (Y2) were statistically significant. Then, these variables were used in verification of method performance characteristics such as accuracy and precision within the method operable range for robustness. The robustness behavior of the method was verified at different points and the result was good with more than 40 % of aqueous phase (X2) at pH of 6.0 (X1) at a flow rate of 0.9 ml min-1 (X3). The method has proven and suitable for regulatory flexibility.
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