RP-HPLC method for analysis of related substances in amoxicillin drug substance

• Autorzy: Raju Ch. B. V. N. , Sharma H. K , Rao Ch. S. , Rao G. N.
• Języki publikacji: EN

Abstrakty

EN

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.

Słowa kluczowe

EN

amoxicillin; N -pivaloylamoxicillin; forced degradation; method validation

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2009
• Tom: Vol. 21, no. 1
• Strony: 57--70
• Opis fizyczny: Bibliogr. 27 poz., rys., tab.

Twórcy

autor

Raju Ch. B. V. N.

autor

Sharma H. K

autor

Rao Ch. S.

autor

Rao G. N.

• Aurobindo Pharma Limited Srikakulam Dist. Pydibhimavaram 532 409 India Andhra University Department of Inorganic and Analytical Chemistry Visakhapatnam 530 003 India,

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