On October 31, 2009, Iuga, Cristina; Bojita, Marius; Leucuta, Sorin E. published an article.COA of Formula: C17H19N3O2S The title of the article was Development of a validated RP-HPLC method for separation and determination of process-related impurities of omeprazole in bulk drugs. And the article contained the following:
A gradient reversed phase liquid chromatog. (RP-LC) method was developed and subsequently validated for the determination of omeprazole and its process-related impurities (noted as: impurity A, B, C, D, G, H). Separation was achieved with a Zorbax Extend C18 column and acetonitrile: water: triethylaminel percent (pH adjusted to 9.5) as eluent, at a flow rate of 0.8 mL/min. UV detection was performed at 280 nm. The described method was linear over a range of 40.6-203 μg/mL for omeprazole, 0.9556-14.334 μg/mL for impurity A, 1.1568-17.352 μg/mL for impurity B, 1.0772-16.158 μg/mL for impurity C, 1.289-19.344 μg/mL for impurity D, and 0.7968-11.952 μg/mL for impurity H. The accuracy of the method was demonstrated at 5 concentration levels in the range of 60-140% of the specification limit and the recovery of impurities was found to be in the range of 90-109%. The method is simple, rapid, selective, accurate, and useful for indicating the stability of omeprazole from dosage forms. The method can be useful in the quality control of bulk manufacturing and pharmaceutical formulations. The experimental process involved the reaction of 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]thio]benzimidazole(cas: 73590-85-9).COA of Formula: C17H19N3O2S
The Article related to omeprazole impurity separation determination rp hplc stability quality, Pharmaceutical Analysis: Synthetic Organic Compounds and other aspects.COA of Formula: C17H19N3O2S
Referemce:
Imidazole – Wikipedia,
Imidazole | C3H4N2 – PubChem