Abstract
A simple, highly selective and stability-indicating high-performance thin-layer chromatographic method was developed and validated for the analysis of baclofen in bulk powder, pharmaceutical formulations and human urine and in and real human plasma. The method employed TLC aluminum plates precoated with silica gel 60 F254 as the stationary phase. The solvent system consisted of butanol–acetic acid–water (3.0: 0.5: 0.5, v/v/v). This system was found to give compact spots for baclofen (Rf value of 0.54). Densitometric analysis was carried out in the absorbance mode at 238 nm. The linear regression analysis data for the calibration plot showed good linear relationship (r2 = 0.9983) in the concentration range 1.5-7.5 µg per spot. The analytical performance of the method was fully validated, and the results were satisfactory. The limits of detection and quantitation were 0.31 and 1.03 µg per spot, respectively. Baclofen was subjected to acid and alkali hydrolysis, oxidation and photodegradation. The degraded product was well separated from the pure drug. Results indicate that the drug is stable against light and basic conditions. However, additional peaks were observed at Rf value of 0.65 and at Rf value of 0.14 with hydrogen peroxide and hydrochloric acid respectively, indicating that the drug is susceptible to oxidation and acid degradation. The method was applied for the analysis of baclofen in commercial tablets and the results were similar to those obtained using the reference method. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one. The high sensitivity of the proposed method allowed determination of baclofen in real human urine and plasma.
Highlights
Baclofen
Aliquot amounts of the dosage forms extract were spiked with extra 50, 100 and 150 % of the standard baclofen and the mixtures were reanalyzed in triplicate by the proposed method
Linearity: “Figure 2” illustrate the linear calibration curve which constructed for baclofen by measuring the peak areas of triplicate bands at ten increasing concentrations 1.5, 2.7, 3.9, 5.1, 6.3, 7.5 μg per spot of baclofen .The curves were constructed by plotting the average peak areas against the corresponding concentration of the spot
Summary
BAL is capable of passing a blood– brain barrier. It is rapidly adsorbed in the human body after oral administration and almost completely recovered unchanged in urine [2]. For HPLC with conventional detection systems, such as UV–vis or fluorescence detectors, BAL needs to be derivatized because solution of BAL does not show obvious absorption or fluorescence For this reason, chemical several derivatizing reagents [11,12,13,14,15,16,17] were applied to transform the analytes into derivatives that can be sensitively detected
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