Sa. Terespolsky et I. Kanfer, STABILITY OF ERYTHROMYCIN AND SOME OF ITS ESTERS IN METHANOL AND ACETONITRILE, International journal of pharmaceutics, 115(1), 1995, pp. 123-128
The stability of erythromycin (EB), erythromycin ethylsuccinate (EES),
propionyl erythromycin (PE) and erythromycin estolate (EE) in methano
l and acetonitrile was investigated. Methanol is widely used asa solve
nt for EB and its ester derivatives in compendial identification tests
as well as in the sample preparation steps during assay procedures. H
PLC with electrochemical detection was used to measure EB concentratio
ns in methanol and acetonitrile solutions - incubated at room temperat
ure (20 +/- 0.5 degrees C) over various periods of time. EB was relati
vely stable in methanol or acetonitrile, remaining intact for over 168
h in acetonitrile and showing less than 5% degradation in methanol ov
er the same period. Approx. 87% of PE remained intact after 168 h in a
cetonitrile whilst methanol caused rapid hydrolysis to EB (35% remaini
ng after 28 h). Similarly, EES was unstable in methanol, showing rapid
and almost complete hydrolysis to EB, with less than 5% remaining aft
er 40 h. Less than 5% degradation, however, occurred over a period of
168 h when EES was dissolved in acetonitrile. EE appeared to be unstab
le in both acetonitrile and methanol. In acetonitrile, only 13% of EE
remained intact after 168 h, whereas in methanol, the degradation was
much more rapid with 35% of EE remaining after 28 h.