Development of analytical and stability testing method for vitamin-A palmitate formulation

Abstract

The present study deals with the stability testing of formulation of Vitamin A palmitate. The aim of this study is to provide the evidences on how the quality of Vitamin A palmitate varies with the time under the influence of variety of environmental factors like temperature, humidity, light, etc. this study is divided into 2 phases. First phase is the method development for VAP on RP-HPLC. In this phase mobile phase selected was methanol 100% (HPLC grade) with detection wavelength of 326 nm. The method shows the good linearity in the range of 25-125 g/ml. Once after the method development method validation was carried out as per the ICH Guidelines. Average percentage recoveries were found to be 98.17%, 98.37, and 98.14%. The %RSD for precision studies was found to be 0.393, 0.719. After that phase of stability testing comes which is divided in two parts first is stress testing which was carried out in different medias like Acid, base, oxidative, UV degradation, Degradation in sun light. Then next phase is of accelerated stability testing in which product is stored at different elevated temperatures at interval of 0, 1, 3, 6 months it was sampled and analyzed by the developed method. The Shelf life was then determined by Arrhenius equations and by Q10 method which was found to be 28 months.