Journal : Acta Chromatographica
Article : RP-HPLC method for analysis of related substances in amoxicillin drug substance

Authors :
Turło, J.
Medical University of Warsaw Department of Drug Technology 1 Banacha Street 02-097 Warsaw Poland Medical University of Warsaw Faculty of Pharmacy 1 Banacha Street 02-097 Warsaw Poland,,
Komsta, Ł.
Medical University of Lublin Chair and Department of Medicinal Chemistry, Faculty of Pharmacy Jaczewskiego 4 20-090 Lublin Poland Medical University of Lublin Chair and Department of Pharmaceutical Botany, Faculty of Pharmacy Chodźki 1 20-093 Lublin Pola,,
Vasta, J. D.
Lafayette College Department of Chemistry Easton PA 18042-1782 USA Lafayette College Department of Biology Easton PA 18042-1782 USA,,
Sajewicz, M.
Silesian University Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland,,
Raju, Ch. B. V. N.
Aurobindo Pharma Limited Srikakulam Dist. Pydibhimavaram 532 409 India Andhra University Department of Inorganic and Analytical Chemistry Visakhapatnam 530 003 India,,
Abstract : Linear gradient HPLC on a C 8 column has been used for separation of individual related substances of amoxicillin listed in the European Pharmacopoeia and a newly identified degradation impurity. The USP plate count for the amoxicillin peak was more than 3000 and USP tailing for the same peak was less than 2.0. Forced degradation studies were conducted on amoxicillin drug substance using ICH stress study guidelines to demonstrate the specificity and stability-indicating nature of the method. A new impurity observed after thermal and alkaline degradation was identified as N -pivaloylamoxicillin. The LOD and LOQ for individual related substances were below 0.045 and 0.086% ( w/w ), respectively. The method was fully validated in accordance with ICH analytical method validation guidelines. The results of the study prove the method is specific, precise, linear, robust, and can be used for evaluation of the stability of amoxicillin drug substance.

Keywords : amoxicillin, N -pivaloylamoxicillin, forced degradation, method validation,
Publishing house : University of Silesia in Katowice
Publication date : 2009
Number : Vol. 21, no. 1
Page : 57 – 70

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Qute : Turło, J. ,Komsta, Ł. ,Vasta, J. D. ,Sajewicz, M. ,Raju, Ch. B. V. N. ,Raju, Ch. B. V. N. , RP-HPLC method for analysis of related substances in amoxicillin drug substance. Acta Chromatographica Vol. 21, no. 1/2009