Stability of ranitidine tablets subjected to stress and environmental conditions, by HPLC.
High Performance Liquid Chromatographic (HPLC) method was applied in this study to comparatively evaluate the stability of tablets in their original package which 150 mg of Ranitidine from six different pharmaceutical laboratories in the market, according to ICH conditions for accelerated testing: 40 degrees C, 75% RH with and without light for six months. The stability at environmental conditions was evaluated for a twelve-month period, with and without light, with the same purpose. Ranitidine is widely used to treat peptic ulcer diseases. Ranitidine is susceptible to degradation under the influence of light, humidity and temperature. The chromatographic conditions were: RP-18 column of 250 mm yen 4 mm ID and a particle size of 5 mm; mobile phase of Acetonitrile-Ammonium acetate solution (0.2 M) (70:30; v/v) (pH*6) adjusted with glacial acetic acid; flow rate of 1 ml min-1; 25 degrees C of temperature; detection at 322 nm; injection volume of 20 ml, using height peak as the integration parameter. The results obtained at six months indicate that the stability of Ranitidine depends on the correct formulation and the primary container. The remaining content of Ranitidine, dissolved percentage in vitro and total impurity percentage were determined by HPLC. Organoleptic characteristics were visually examined. The proposed analytical method was validated and linearity, precision and selectivity were determined. Degradation products were detected.
Volonté
M G
MG
Cátedra de Ensayo y Valoración de Medicamentos, División Farmacia, Departamento de Ciencias Biológicas, Facultad de Ciencias Exactas, Universidad Nacional de La Plata, La Plata, Argentina.
Yuln
G
G
Mandrile
A
A
Longo
R
R
Cingolani
A
A
D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004777:Environment; D011899:Ranitidine / Q000032:analysis*; D015203:Reproducibility of Results; D012995:Solubility; D013607:Tablets
D013607:Tablets; D011899:Ranitidine