Rapid and Simultaneous Determination of Diltiazem Related Compounds Containing Optical Isomer Impurities in the Drug Substance and its Formulations Using a 3 μm Chiral Column Immobilized with Ovomucoid

NISHI Hiroyuki, SASAKI Mia-Christina, IWATA Nana, KAWABATA Kohei

doi:10.2116/bunsekikagaku.72.363

<p>This paper describes the development of a rapid simultaneous HPLC evaluation method of related substances and optical purity of diltiazem (cis-(+)-(2S, 3S) form) and its formulations by employing a 3 μm ovomucoid conjugated chiral column. After optimization of the mobile phase, changing organic solvent species and its concentration, buffer species and concentration, buffer pH etc., successful simultaneous determination of its deacetyl form (diltiazem main impurity and degradation product) and a minor enantiomer (cis-(-)-(2R, 3R) form) was achieved within 2.5 min. The mobile phase used was a mixture of acetonitrile and 0.02 mol L⁻¹ ammonium acetate buffer (pH 6.0) (12.5 : 87.5). By employing the developed HPLC method with a 3 μm ovomucoid column, no minor enantiomer and 0.1 %-0.4 % deacetyl form were found in all diltiazem drug substances, its tablets and injections (freeze-dried formulations) (cis-(+)-(2S, 3S) form), and they were stored at a room temperature for more than 10 years, showing diltiazem and its formulations are very stable pharmaceuticals.</p>

Rapid and Simultaneous Determination of Diltiazem Related Compounds Containing Optical Isomer Impurities in the Drug Substance and its Formulations Using a 3 μm Chiral Column Immobilized with Ovomucoid

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