A novel gradient HPLC method for simultaneous determination of ranitidine, methylparaben and propylparaben in oral liquid pharmaceutical formulation.
A selective and accurate high-performance liquid chromatographic method has been developed and validated for the simultaneous determination of ranitidine, methylparaben (MP) and propylparaben (PP) in oral liquids. Samples were purified by solid-phase extraction (SPE) using a copolymeric [poly(divinylbenzene-co-N-vinylpyrrolidone)] sorbent. The chromatographic separation was achieved by HPLC using a mixture of ammonium acetate solution (0.5 M), acetonitrile and methanol as the mobile phase with gradient elution, a Nucleosil C18 column and UV detection at 254 nm. The method was validated with respect to linearity, precision, accuracy, selectivity, and robustness. All the parameters examined met the current recommendations for bioanalytical method validation. The method was found to be applicable to routine analysis (assays and stability tests) of active compound (ranitidine) and preservatives (MP and PP).
Kokoletsi
Magdalene Xenou
MX
R&D Laboratory, Quality Control Department, DEMO SA Pharmaceutical Industry, 21st km National Road Athens-Lamia, 14568 Athens, Greece. mxenou@demo.gr
Kafkala
Stella
S
Tsiaganis
Michael
M
D000897:Anti-Ulcer Agents / Q000032:analysis*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D010226:Parabens / Q000032:analysis*; D019999:Pharmaceutical Solutions; D011899:Ranitidine / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
D000897:Anti-Ulcer Agents; D010226:Parabens; D019999:Pharmaceutical Solutions; D011899:Ranitidine; C015358:methylparaben; C006068:propylparaben