Amoxicillin sodium-potassium clavulanate: evaluation of gamma radiation induced effects by liquid chromatography on both the individual drugs and their combination
L. Valvo et al., Amoxicillin sodium-potassium clavulanate: evaluation of gamma radiation induced effects by liquid chromatography on both the individual drugs and their combination, J PHARM B, 21(1), 1999, pp. 9-14
The effects of gamma irradiation on the stability of potassium clavulanate,
amoxicillin sodium and their combination were investigated. A decrease in
purity and increase in degradation products up to 30 days after the irradia
tion were evaluated by reversed phase HPLC. The comparison between unirradi
ated and irradiated amoxicillin sodium, performed within 24 h following the
irradiation process, showed no significant increase in the pre-existing im
purities and no evidence of newly induced degradation products. On the cont
rary, an appreciable increase in the content of some impurities was evidenc
ed 30 days after the irradiation. The chromatographic profile of irradiated
potassium clavulanate showed the appearance of one unidentified new produc
t and a slight increase of one pre-existing impurity. No further change in
the impurity content was noted 30 days after the irradiation. The amoxicill
in sodium-potassium clavulanate combination underwent the same kind of radi
ation induced degradation as the single compounds. (C) 1999 Elsevier Scienc
e B.V. All rights reserved.