Ranitidine hydrochloride: development of an isocratic stability--indicating high-performance liquid chromatographic...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Ranitidine hydrochloride is a widely used medication.
• Ensuring the stability and purity of ranitidine hydrochloride is crucial for patient safety and drug efficacy.
• Existing analytical methods may not adequately separate all potential impurities and degradants.

Purpose of the Study:

• To develop and validate a stability-indicating assay for ranitidine hydrochloride.
• To ensure the method can separate known and unknown impurities and degradants.
• To establish the assay's suitability for determining purity, identity, and strength in active ingredients and finished dosage forms.

Main Methods:

• Development of a stability-indicating assay using High-Performance Liquid Chromatography (HPLC).
• Utilized a mobile phase with an added ion-interaction reagent for enhanced separation.
• Analyzed placebo samples to confirm no interference with the separation.

Main Results:

• The developed assay successfully separated all known and unknown impurities/degradants of ranitidine hydrochloride.
• The assay demonstrated linearity over a concentration range of 0.056 to 44.4 microg/g.
• Achieved a limit of detection (LOD) of 0.028 microg/g and a limit of quantitation (LOQ) of 0.056 microg/g.
• System precision was determined to be 0.7%.

Conclusions:

• A robust stability-indicating assay for ranitidine hydrochloride has been successfully developed.
• The assay is suitable for routine quality control, including purity, identity, and strength testing.
• The method provides reliable separation of ranitidine hydrochloride from its impurities and degradants.