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Abstract

An Improved Method For Separation Of Diltiazem And Related Substances By HPLC

Author(s): M. K Sastry, P. K Chakrabarti, R. K Nanda, S. R Naik

A simple, sensitive method has been developed for separation and estimation of cis-isomers (Des Acetyl Diltiazem and Des Acetyl Diltiaze-5H) present in Diltiazem HCl as related compounds. The present work involves the separation of these isomers from Diltiazem HCl which are normally accompanied with the bulk during the synthesis. The composition of the solvent system and the flow rate are optimized using Hypersil-ODS, 5 micron reverse phase column to achieve conditions for better and effective separation. The method is found to be rapid and reliable for routine quality control analysis of bulk and dosage form preparation of diltiazem. The results of the recovery experiments are also incorporated as a part of process validation. When compared with the USP method, the proposed method is found to be more sensitive and provides a better peak shape for each component of the chromatogram.

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