Development of an HPLC Method for Determining Baclofen

Dukova, Olga A.; Krasnov, E. A.; Efremov, A. A.

doi:10.1007/s11094-015-1172-5

Cited by 13 publications

(8 citation statements)

References 6 publications

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“…Moreover, a simple reported HPLC method [29] was applied for assay of BAC in its tablets. The reported method was designed using C18 column (250 × 4.6 mm, 5μm) as stationary phase, acetonitrile/orthophosphoric acid pH 3.5 as mobile phase and UV detection at 220 nm.…”

Section: Resultsmentioning

confidence: 99%

“…Thorough literature survey revealed that chromatographic methods, mainly HPLC, are the mostly used methods for BAC analysis. Such as, HPLC with UV detection [2], determination in human plasma by HPLC with several detection methods including tandem mass spectrometry (MS-MS) [3, 4], high-resolution mass spectrometry (HR-MS) [5] and fluorescence detection [6, 7]. In addition, ultra-performance liquid chromatography coupled with MS-MS detection has been used for detecting BAC in blood samples [8].…”

Section: Introductionmentioning

confidence: 99%

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

El-Yazbi

Guirguis

Bedair

et al. 2019

Heliyon

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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.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

El-Yazbi

Guirguis

Bedair

et al. 2019

Heliyon

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“…[ 9 ] Electrochemical methods such as potentiometry have been used. [ 10,11 ] Methods dependent on separation involved techniques such as high performance liquid chromatography (HPLC), [ 12–14 ] HPTLC, [ 15 ] and capillary electrophoresis. [ 16,17 ]…”

Section: Introductionmentioning

confidence: 99%

A new feasible approach based on utility of ninhydrin for selective fluorimetric analysis of baclofen. Application to content uniformity evaluation

2020

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In the current proposed analysis, a new, feasible, and selective fluorimetric approach was designed for baclofen assay. Baclofen is a medication prescribed as a therapy for muscle spasticity that originated from multiple sclerosis or a spinal cord injury, and other cases such as hiccups. The analytical approach relies on the use of ninhydrin to form a fluorescent derivative that was monitored at λex 386 nm or λem 480 nm. Under suitable reaction conditions, the primary amino moiety in baclofen was condensed with ninhydrin and phenylacetaldehyde in the presence of Teorel buffer as a buffered medium. The method exhibited linearity when baclofen concentration was plotted against response in the range 1–10 μg ml−1. Adjustment of the reaction variables and study of validation parameters according to ICH directives were performed correctly. An interference study was implemented to ensure that no discrepancy from the excipient had occurred. Finally, the proposed method was applied successfully for baclofen assay in dosage form and extended to test Mylobac content uniformity.

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“…Besides the high cost of the ion pairing reagents, this technique requires a column pre-and post-conditioning step, increasing the analysis time and the solvent waste (7). Several methods for the determination of baclofen in different matrices by HPLC reverse phase are reported in the literature, but none of them is indicative of stability (8)(9)(10)(11)(12)(13)(14)(15)(16). Such studies are of great importance since no product is stable indefinitely, and they are performed to monitor the product throughout its shelf life, as well as the generation of toxic or inactive products (17)(18)(19)(20)(21).…”

Section: Introductionmentioning

confidence: 99%

Validation of a Simple Reversed Phase-HPLC Method for the Determination of Baclofen in Tablets

2018

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Baclofen is a muscle relaxant used as a first option to treat spasticity and muscle spasms in patients with spinal cord injuries, which is available in Brazil as 10 mg tablets. The compendia methods employ HPLC by ion pairing that requires the use of specific reagents and column conditioning, increasing the waste generation and the cost of analysis. In this study, an isocratic, simple and stability-indicating HPLC method was validated to assay baclofen tablets. A C-18 column (Luna®, 150 x 4.6 mm, 5μm), mobile phase composed by triethylamine 10 mM pH 7.0, methanol and acetonitrile (80:15:5), flow rate 1 mL/min and detection at 220 nm was used. The baclofen retention time was 6.2 min and the method was linear in the range of 5 – 100 μg.mL-1 (r = 0.9999). Method selectivity was demonstrated by the forced degradation study and simultaneous analysis of baclofen impurity. The method showed accuracy (mean recovery 99.27%) and precision (RSD < 2%). The robustness was evaluated by factorial design, and the method was robust robust regarding the proposed variations. The developed method met the requirement of current guidelines, being indicative of stability and suitable for the determination of baclofen in tablets.

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Development of an HPLC Method for Determining Baclofen

Cited by 13 publications

References 6 publications

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

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

A new feasible approach based on utility of ninhydrin for selective fluorimetric analysis of baclofen. Application to content uniformity evaluation

Validation of a Simple Reversed Phase-HPLC Method for the Determination of Baclofen in Tablets

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