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Abstract
The USP HPLC method for related compounds in nifedipine has been modified to improve resolution and sensitivity. the modified method uses a Novopak' CI8 column with a mobile phase consisting of 48% methanol in water. This method has been validated for the determination of drug and related compounds in drug raw materials; it has been shown to resolve at least seven known related compounds from the drug, with quantitation limits ranging from 0.01 to 0.10%. Total impurities in 15 samples of drug raw material were between 0.02 and 0.85%. the drug content of these samples ranged between 97.9 and 102.0%.