Simple mix-and-read assays for the determination of baclofen in pharmaceutical formulation

Abstract

This study demonstrates three simple and inexpensive spectrophotometric mix-and-read assays for the determination of the skeletal muscle relaxant, baclofen (BAC) in pharmaceutical formulations. The proposed methods are based on the reaction of the primary amine group of BAC with various derivatizing reagents to yield different colored products. Method I depends on the reaction of BAC with vanillin in borate buffer pH 11.5 to give a yellow colored product with maximum absorbance at 401 nm. While method II describes the reaction with eosin Y in citric-phosphate buffer pH 2.2 forming an orange-red product measured at 548 nm. Method III depends on Hantzsch condensation reaction that yields a yellow product measured at 339 nm. Different experimental variables influencing development and stability of the obtained colored product are optimized. Validation of the three methods regarding linearity, ranges, precision, accuracy and limits of detection and quantification was performed. Regression analysis showed good linearity over the concentration ranges of 10–35, 5–20 and 5–25 μg/mL for methods I, II and III, respectively with correlation coefficient values not less than 0.999. Additionally, detection limits of BAC are 1.58, 0.94 and 0.79 μg/mL for methods I, II and III, respectively. Finally, the suggested procedures are successfully used for assay of BAC in its tablets. The main advantages of the proposed mix-and-read assays are being inexpensive and rapid with no requirement for laborious extraction techniques with equivalent or superior sensitivity compared to other published spectrophotometric procedures. Such advantages promote the suggested methods for the high throughput assay of BAC dosage forms, a critical component in quality control studies for pharmaceutical industries.