Analytical Method Development and Validation of Estimation of Vitamin E Acetate From Multi-Vitamin Dosage From Quality by Design(QbD) Approach

Abstract

A simple, efficient and reproducible RP-HPLC method for determination of Vitamin E Acetate from multivitamin tablet dosage form has been developed and validated using Quality by Design approach. As vitamin E acetate is a fat soluble vitamin. It requires extraction from multivitamin dosage form. The extraction was carried out by using n- Hexane and Dimethyl sulfoxide (DMSO). The chromatographic separation was carried out using Partisil ODS-3 (100 mm × 4.6 mm, 5μ) column using the mobile phase consist of Methanol: Acetonitrile:1% OPA in water (75:20:5). The flow rate was 1.0 ml/min and effluent was detected at 254 nm. The retention time of vitamin E Acetate was 6.96. Qualityby Design approach was applied to reduce the development trials for optimization ofanalytical method. Miscellaneous Response Surface Methodology was applied in Design Expert software. Column Temperature and Acetonitrile composition in mobile phase were two critical parameters observed. The response was on number of Plate counts and Retention time of vitamin E Acetate. Other graphs such as Contour plot and 3D surface were obtained from software, have been useful to understand the response of factors on analytical method. Chromatographic peak purity results indicated the absence of co‐eluting peaks with the main peak of vitamin E Acetate. The method was validated using ICH Guideline and the acceptance criteria for system suitability, specificity, accuracy, linearity, precision were met in all classes. Linearity was found in the range of 0.03 – 0.09 IU. Correlation coefficient (r2) obtained was 0.9993. Values of all the parameters were within the prescribed limits.