PHYSICOCHEMICAL CHARACTERIZATION OF VENLAFAXINE HYDROCHLORIDE FOR FAST-DISSOLVING FORMULATION DESIGN

Abstract

Objective: The study focuses on the characterization of Venlafaxine Hydrochloride through a series of physicochemical evaluations to ensure its suitability for pharmaceutical development.
Experimentation: Organoleptic properties such as color, odor, and appearance were assessed. The melting point was determined using a capillary method with an average value calculated from three trials. UV spectrophotometric analysis in ethanol was performed to identify the maximum absorbance wavelength. A standard curve of calibration was plotted using absorbance values from prepared dilutions (5–30 μg/mL). Solubility studies were conducted distilled water and in various solvents (methanol, ethanol, and acetone) as well as phosphate buffer 6.8 pH to evaluate equilibrium solubility, while the distribution coefficient (Kp) was calculated using the shake-flask method with octanol and water to estimate lipophilicity. The pH of a freshly prepared 0.1M solution of Venlafaxine HCl in distilled water was measured. Finally, compatibility with excipients was studied using DSC and FTIR to detect potential chemical interactions.
Result & Discussion: The physicochemical parameters like melting point, λ max, solubility, and partition coefficient were found to be 217±0.08 OC, 224.8 nm, 401±0.45 mg/ml, and 395 mg/ml. 25 mg/ml, 0.8 mg/ml and 23 mg/ml respectively. The pH of Venlafaxine HCl was found to be 6.8. From the FTIR & DSC spectra, since all of the drug's distinctive peaks were preserved, it is evident that the drug and excipients are compatible. Therefore, the API and these excipients are not incompatible.
Conclusion: This comprehensive characterization provides foundational data for fast dissolving formulation design and stability evaluation of Venlafaxine HCl.