ABSTRACT
The optimization of HPLC method involves several variables whose influence has been widely studied. However, inmost of the cases, only process variables are taken into account. In this work, the influence of mixture compositionon peak quality parameters of Pitavastatin calcium in bulk and tablet dosage form has been studied using a mixturesimplex design. A simplex centroid design with axial points in a pseudo-component representation was generated fromthe pure mixture components. Twelve ternary mixture mobile phases corresponding to augmented design points weretested to separate the drug in sample. The statistical analysis was performed to generate the polynomial equation foreach response. The desirability approach was used to determine the optimal mobile phase composition. Furthermore,the method was validated as per the ICH guidelines using specificity, linearity, accuracy, precision, sensitivity, systemsuitability, and robustness. The results of experimental design were statistically tested for full and in portion to getbest fitted model which accurately describe changes in the proportion of these solvents in the mobile phase close to theregion of optimal peak quality. The method demonstrated optimum chromatographic separation with isocratic elutionof the mobile phase containing a mixture of acetonitrile-water (pH 3.0)-tetrahydrofuran (43:55:02, v/v/v) with a flowrate at 1.0 ml/minute. Design of experiment optimization strategy is a powerful tool to acquire the maximum qualitydata while performing minimum number of experiments. The mobile phase composition was successfully optimizedusing simplex centroid mixture design with desirability approach. Additionally, developed method can be appliedfor routine quantitative analysis of Pitavastatin calcium in bulk and tablet dosage form as it was found to be simple,sensitive, and robust.
ABSTRACT
The present study demonstrates the application of 32 full factorial design for optimization of berberine loaded liposome for oral administration. Thin film hydration method was used to prepare liposome and optimization was done by 32 full factorial designs combined with desirability function. Nine formulations were prepared by using different drug : lipid and soyphosphatidylcholine : cholesterol (SPC:CHOL) ratios and evaluated for entrapment efficiency and vesicle size. The statistical validity of model was done by analysis of variance (ANOVA). Response surface graph and contour plots were used to understand the effect of variables on responses. The optimized formulation with 0.782 desirability value was prepared and evaluated for responses. The results of entrapment efficiency and vesicle size were found to be very close with the predicted values. In addition, an optimized formulation was also characterized for zeta potential, in vitro drug release and morphology. The formulation was found to be spherical shape with an average diameter of 0.823 nm and -1.93 mV zeta potential and also shows sustained release pattern. These results support the fact that 32 full factorial designs with desirability function could be effectively used in optimization of berberine loaded liposome.