Determination of cimetidine, famotidine, and ranitidine hydrochloride in the presence of their sulfoxide derivatives in pure and dosage forms by high-performance thin-layer chromatography and scanning densitometry.
A selective, precise, and accurate method was developed for the determination of cimetidine (C), famotidine (F), and ranitidine hydrochloride (R x HCl) in the presence of their sulfoxide derivatives. The method involves quantitative densitometric evaluation of mixtures of the drugs and their derivatives after separation by high-performance thin-layer chromatography on silica gel plates (10 x 20 cm) with ethyl acetate-isopropanol-20% ammonia (9 + 5 + 4, v/v) as the mobile phase for both C and F and ethyl acetate-methanol-20% ammonia (10 + 2 + 2, v/v) as the mobile phase for R x HCl; Rf values for C, F, and R x HCl and their corresponding derivatives were 0.85 and 0.59, 0.73 and 0.41, and 0.56 and 0.33, respectively. Developing time was approximately 20 min. For densitometric evaluation, peak areas were recorded at 218, 265, and 313 nm for C, F, and R x HCl, respectively. The relationship between concentration and the corresponding peak area was plotted for the ranges of 5-50 microg/spot for C and 2-20 microg/spot for F and R x HCl. Mean recoveries were 100.39 +/- 1.33, 99.77 +/- 1.30, and 100.09 +/- 0.69% for C, F, and R x HCl, respectively. The proposed method was used successfully for stability testing of the pure drugs in the presence of up to 90% of their degradates, in bulk powder and dosage forms. The results obtained were analyzed statistically and compared with those obtained by the official methods.
Kelani
Khadiga M
KM
Cairo University, Faculty of Pharmacy, Department of Analytical Chemistry, Egypt.
Aziz
Azza M
AM
Hegazy
Maha A
MA
Farrah
Laila Abdel
LA
D002138:Calibration; D002855:Chromatography, Thin Layer; D002927:Cimetidine / Q000032:analysis*; D003720:Densitometry; D015738:Famotidine / Q000032:analysis*; D006635:Histamine H2 Antagonists / Q000032:analysis*; D007202:Indicators and Reagents; D011208:Powders; D011899:Ranitidine / Q000032:analysis*; D015203:Reproducibility of Results; D013454:Sulfoxides / Q000032:analysis; D013607:Tablets
D006635:Histamine H2 Antagonists; D007202:Indicators and Reagents; D011208:Powders; D013454:Sulfoxides; D013607:Tablets; D015738:Famotidine; D002927:Cimetidine; D011899:Ranitidine