Фармацевтика Аналитика Акта

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Enantiomeric Separation and Determination of Stereospecific Drug Release from Marketed Racemic Amlodipine Besylate Tablets by HPLC

Jagan Mohan Somagoni, Sunil Reddy, Someshwar Koorelli, Sarangapani Manda and Madhusudan Rao Yamsani

The objective of carrying out this research work was to investigate the effect of chirality on the stereospecific dissolution of amlodipine from various marketed racemic amlodipine besylate tablets. Amlodipine is a calcium ion influx inhibitor which is used in the treatment of hypertension and angina.

In this study dissolution of various marketed tablets was performed using USP type II apparatus in 0.1 N HCl at 75 rpm with temperature being maintained at 37±0.5 o C. Chromatographic separation of amlodipine enantiomers was performed using HPLC equipped with UV-Visible detector using Chiral AGP column (100 x 4.6 mm I.D., 5μ particle size). There was no significant difference between the cumulative drug release profiles of S and R enantiomers (p>0.05) in 16 out of 20 marketed racemic amlodipine besylate tablets except for amlong, stamlo-5, amlopin-5 and amcard (p<0.05). Though the stereospecificity in the dissolution was found with the four brands i.e., amlong, stamlo-5, amlopin-5 and amcard, the stereospecificity found with Stamlo-5 was quite opposite to the stereospecificity of amlong, amlopin-5 and amcard because the dissolution of R enantiomer of amlong, amlopin-5 and amcard was significantly more compared to their S enantiomer where as in the case of stamlo-5 the dissolution of S enantiomer was more compared to its R enantiomer.