US EPA

8224746 

Journal Article 

Separation and simultaneous quantitation of meclizine hydrochloride and pyridoxine hydrochloride in their solid and semi-solid preparations using validated HPLC method 

Al-Kafri, NAA; Al-Mardini, MA 

2013 

21 

1 

138-142 

English 

The purpose of this work was to develop a rapid, sensitive and validated HPLC (High Performance Liquid Chromatography) method for separation and analysis of pyridoxine hydrochloride and meclizinehydrochloride in their solid and semi-solid preparations. The two compounds were separated on a reversed-phase C18 silica column (250 x 4.6 mm) using a mobile phase containing dodecyl sulphate sodium salt dissolved in a mixture of water, acetonitrile, methanol, glacial acetic acid and tetrahydrofuran. The pH was adjusted to pH= 3.8 by the addition of hexane sulphonic acid sodium salt ion-pair reagent. The samples were detected using a UV detector at 253 nm. The validation study of the method included the effect of the flow rate, ratio of the components of the mobile phase and the pH of the mobile phase on the efficiency of separation. The linearity, accuracy, precision, specificity and robustness of the developed method showed acceptable values. The method was applied to the analysis of the samples of the two compounds under the study. The developed method is suitable for quality control (QC) of meclizine hydrochloride and pyridoxine hydrochloride in their pharmaceutical preparations (tablets and suppositories). 

HPLC; Meclizine; Pyridoxine; Validation method