HPLC-UV method validation for quantification of β-carotene in the development of sustained release supplement formulation containing solid dispersion-floating gel in situ

Despite the health benefits of β-carotene, its activity has been hampered by poor aqueous solubility and low oral bioavailability. Therefore, it is crucial to develop a new approach to overcome these problems. In this study, we developed a dry powder supplement comprising a combination approach of solid dispersion and floating gel in situ of β-carotene to enhance the solubility and achieve sustained release behavior. Here, we validated an HPLC method to quantify β-carotene as per the guidelines from ICH. The analytical method was validated in methanol and Fasted-State Simulated Gastric Fluid (FaSSGF) to determine β-carotene in recovery and in vitro release studies, respectively. A simple HPLC method using Xselect CSH™ C18 column (Waters, 3.0 × 150 mm) with the particle size of 3.5 µm was validated with 100% acetonitrile as the mobile phase. The calibration curves were found to be linear with LLOQ values