Formulation of Baclofen Microemulsion and Validation of Analytical Method for Quantitative Estimation by UV Spectroscopy

Abstract

Introduction: Baclofen is a centrally acting antispasmodic drug used to treat muscular spasticity by acting on SNP and multiple sclerosis. Baclofen is hydrophilic in nature, can’t cross the BBB, and results have 60% bioavailability.

Objectives: The objectives of the current study were to formulate a microemulsion of Baclofen in order to increase its bioavailability and to develop, optimise, and validate an analytical method for the estimation by UV-Visible spectrophotometer.

Methods: Four different batches were formulated on the basis of S/Cos ratios 3:1, 3.5:1, 4.5:1, and 1.5:1 respectively by water titration method. Tween 80, Span 80 and PEG 400 were blended together to form a homogeneous mixture, Baclofen was dissolved in oil phase. Oil phase and surfactant mixture were mixed slowly with continuous trituration for 30 minutes at 3000 rpm on a magnetic stirrer. The result of FTIR study were indicated compatibility in between Baclofen and excipients.

Results: On the basis of solubility studies, 0.1 N NaOH was selected for analytical method validation. The ƛ_max and regression equation found to be 221nm and Y=0.0603x+0.0207, R²= 0.999. The results of all analytical validation parameters were < 2% RSD value. Out of all batches M1 shows more transparent, no phase separation, pH of 6.7, particle size 100nm, low viscosity and 96.73% drug content value. It exhibited good stability over the course of the six-month stability study, with no significant changes in its physicochemical characteristics.

Conclusions: On the basis of the finding, it was concluded that M1 batch is a feasible, effective and it boosts the bioavailability of Baclofen.