Estimation of impurity profiles of drugs and related materials Part 18. Impurities and degradation products of Mazipredone (cas 13085-08-0)

Add time:09/25/2019    Source:infona.pl

Reversed-phase HPLC methods using C-18 and C-8 columns as well as various isocratic and gradient systems with aqueous ammonium acetate, methanol and acetonitrile are described for the separation of the impurities of mazipredone (11β,17-dihydroxy-21-(4-methyl-1-piperazinyl)-pregna-1,4-diene-3,20-dione hydrochloride). These methods were used also for the estimation of the hydrolytic and oxidative degradation pathways of mazipredone in 0.1 M hydrochloric acid and sodium hydroxide at 80 ^o C. With the aid of HPLC-(APCI)-MS and HPLC-diode-array UV techniques 15 impurities and degradation products have been identified.

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