Validated Smart Different Chromatographic Methods for Selective Quantification of Acefylline Piperazine, Phenobarbital Sodium and Methylparaben Additive in Bulk and Pharmaceutical Dosage Form.

Two chromatographic methods have been proposed for the simultaneous determination of acefylline piperazine (ACEF) and phenobarbital (PHENO) in presence of methylparaben as additive in pharmaceutical dosage form. The first method was thin-layer chromatography. The separation was achieved using silica gel as stationary phase and chloroform: methanol: glacial acetic acid (2.0, 8.0 and 0.1, by volume) as a developing system at 254 nm. Accurate determination of both drugs was attained over the concentration range of 0.5-25 μg/band. The second method was based on the use of reversed phase liquid chromatography with diode array detection, by which the proposed components were separated on a reversed phase C18 analytical column using methanol: water (60: 40, by volume) as a mobile phase with flow rate of 0.8 mL/min at 214 nm in a concentration range of 0.5-100 μg/mL. The proposed chromatographic methods were practiced successfully for the determination of ACEF and PHENO in pharmaceutical dosage form. Both methods were validated according to the International Conference on Harmonization guidelines and statistically compared with a reported high-performance liquid chromatograph method. Planar chromatography has never been proposed in the literature for ACEF and PHENO determination besides the proposed columnar chromatographic method using an isocratic eco-friendly mobile phase.