METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF APREPITANT USING HYDROTROPY

Solubilization of poorly soluble pharmaceuticals is a recurring challenge in screening testing of novel chemical entities as well as formulation design and development. The most effective method for improving a drug's water solubility is the hydrotropic solubilization process. This study's main goal was to create a simple ecofriendly method development & validation for procedures for estimation of aprepitant using hydrotropy. The Solubility results showed that the drug aprepitant was freely soluble in 2M Sodium acetate: 2M Sodium Benzoate (1:1). ). Also, remarkable 15-fold increase in solubility of aprepitant was seen with this combination. The maximum absorbance of Aprepitant was observed at 264 nm respectively. The linearity results indicate that aprepitant was entirely soluble in 2M Sodium acetate: 2M Sodium Benzoate (1:1) and the graph are linear. The rate of solubility increases as the graph becomes more linear. Further at recovery level of 120% the % recovery obtained was 99.32±0.704. The repeatability precision was noticed as 99.416±0.107. The precision in reproducibility of result was estimated to be 99.34±0.111. The % RSD in Day to day & analyst to analyst was estimated as 99.06±0.110 and 98.98±0.233 respectively. The analysis of aprepitant tablet with 80 mg label claim showed that actual drug amount as 79.45 mg. So, the % label claim becomes 99.31. Also, the S.D & 5 R.S.D value revealed to be 0.225 & 0.341 respectively.  Thus, it can be concluded that newly developed eco-friendly Hydrotropic Solubilization process can be successfully used to improve the solubility of drug that is weakly aqueous soluble aprepitant is accurate and exact.

Keywords: Hydrotropy, Method development, Validation, Aprepitant, Eco friendly, Solubalization