A validated chiral HPLC method for the determination of mebeverine HCl enantiomers in pharmaceutical dosage forms and spiked rat plasma

Abstract

A new, precise, simple and accurate HPLC method was developed for the first time to separate and determine mebeverine enantiomers. Enantiomeric resolution was achieved on a cellulose Tris (3,5-dimethylphenyl carbamate) column known as Chiralcel OD, with UV detection at 263 nm. The mobile phase consisted of n-hexane, isopropyl alcohol and triethylamine (90:9.9:0.1 v/v/v). Sample run time was 18 min. On using the chromatographic conditions described, mebeverine enantiomers were well resolved with mean retention times of about 11 and 14 min. A linear response (r > 0.999) was observed over the concentration range 0.5-20 µg/mL racemic mebeverine. Precision, accuracy and stability were studied according to ICH guidelines. The limit of detection was found to be 0.05 µg/mL for each enantiomer of mebeverine. The proposed method was applied for analysis of mebeverine in commercially available tablets dosage formulations. Examples of application to biological samples are also given. Reanalysis of samples several weeks after the initial analysis showed no degradation of mebeverine. Copyright

Quantitative HPLC analysis of mebeverine, mesalazine, sulphasalazine and dispersible aspirin stored in a Venalink monitored dosage system with co-prescribed medicines

“…It has been used for the quantitative determination of mebeverine HCl [11][12][13][14] and its stability in tablets [15], for the determination of 5-aminosalicylic acid (5-ASA) [16][17][18][19][20] and the stability of 5-ASA and its metabolites in plasma [21,22], for sulphasalazine [23,24] and for aspirin [25][26][27][28][29].…”

Rapid and sensitive determination of donepezil in human plasma by liquid chromatography/tandem mass spectrometry: application to a pharmacokinetic study

“…Previous investigations have shown that donepezil in biological fluids can be detected using high‐performance liquid chromatography (HPLC) equipped with a ultraviolet (UV),6–12 fluorescence (FL),13, 14 or mass spectrometric (MS)15–19 detector. The HPLC/UV method has been used to determine donepezil in human plasma,12, 13, 15, 19 but the method is insensitive (≥1.0 ng/mL) and requires a large volume of blood sample (≥1.0 mL) 6–12. Radwan et al 12.…”

“…The HPLC/UV method has been used to determine donepezil in human plasma,12, 13, 15, 19 but the method is insensitive (≥1.0 ng/mL) and requires a large volume of blood sample (≥1.0 mL) 6–12. Radwan et al 12. have reported a stereoselective HPLC/UV assay for determining donepezil enantiomers.…”

Thin-layer chromatography method for the simultaneous quantification and stability testing of alprazolam and mebeverine in their combined pharmaceutical dosage form

“…A survey of the literature revealed that alprazolam can be estimated by spectrophotometry [5] and liquid chromatographic methods [6][7][8][9][10][11], individually or in combination with other drugs, while mebeverine can be estimated by liquid chromatographic methods individually or concurrently with other drugs [12][13][14][15][16]. The reported methods are highly sophisticated, costly, and time-consuming, often requiring special sample preparation.…”