Development and validation of chromatographic methods for simultaneous determination of ibuprofen and famotidine in presence of related substances in pharmaceutical formulations.

Content Provider	Semantic Scholar
Author	Elzanfaly, Eman Saad Zaazaa, Hala El-Sayed Soudi, Aya T. Salem, Maissa Yacoub
Copyright Year	2015
Abstract	Two validated methods for the simultaneous determination of ibuprofen and famotidine in the presence of ibuprofen impurity (4-isobutylacetophenone) and or famotidine degradation products were described. The first method was a simple TLC method where separation was performed on silica gel platesusing ethyl acetate: methanol: ammonia (9:2:1, by volume) as a mobile phase. Rf values were found to be 0.40, 0.94, 0.66, 0.27, 0.83 for ibuprofen, 4-isobutylacetophenone, famotidine, famotidine acid and basic degradation products, respectively. The second method is by HPLC on C18 column using methanol: phosphate buffer pH 3 (80:20, v/v) as a mobile phase. Retention times were found to be 2.2, 9.9, and 8.6 for famotidine, ibuprofen, and 4-isobutylacetophenone, respectively. Both methods were validated according to the ICH guidelines and applied for the determination of the two drugs in pure powder and combined dosage form without interference from the excipients.
Starting Page	45
Ending Page	51
Page Count	7
File Format	PDF HTM / HTML
Alternate Webpage(s)	https://journals.matheo.si/index.php/ACSi/article/viewFile/703/406
PubMed reference number	25830959v1
Volume Number	62
Issue Number	1
Journal	Acta chimica Slovenica
Language	English
Access Restriction	Open
Subject Keyword	4-isobutylacetophenone Ammonia measurement Dosage Forms Eluent Famotidine Ibuprofen Methanol PHOSPHATE BUFFERS Pharmaceutical Excipient Silica Gel Silicon Dioxide Thin Layer Chromatography Volume fraction ethyl acetate inorganic phosphate substance
Content Type	Text
Resource Type	Article