Ranitidine hydrochloride: development of an isocratic stability--indicating high-performance liquid chromatographic separation.
The development of a stability-indicating assay for ranitidine hydrochloride using a mobile phase added ion-interaction reagent was achieved. The assay easily separated all known and unknown impurities/degradants. This assay may be used for the determination of purity, identity and strength for the active ingredient and finished dosage forms. Placebo samples were analyzed for all of the dosage forms and did not interfere with the separation. The system was found to be linear over a range of 0.056 to 44.4 microg/g, with a limit of detection of 0.028 microg/g and a limit of quantitation of 0.056 microg/g. The system precision was determined to be 0.7%. The development of the stability-indicating assay and the effect that each chromatographic variable had on the separation will be discussed.
Munro
J S
JS
Atrix Laboratories, Fort Collins, CO 80525-4417, USA.
Walker
T A
TA
D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004304:Dosage Forms; D006863:Hydrogen-Ion Concentration; D010756:Phosphoric Acids / Q000737:chemistry; D010919:Placebos; D011899:Ranitidine / Q000302:isolation & purification*; D012015:Reference Standards; D012680:Sensitivity and Specificity; D012967:Sodium Dodecyl Sulfate / Q000737:chemistry
D004304:Dosage Forms; D010756:Phosphoric Acids; D010919:Placebos; D012967:Sodium Dodecyl Sulfate; D011899:Ranitidine; C030242:phosphoric acid