Development of a Validated Stability Indicating HPLC Method for Ranitidine Hydrochloride Syrup

Abstract

An isocratic reversed-phase high-performance liquid chromatographic method was developed and validated for the determination of ranitidine HCl in syrup. The samples were analyzed by high-performance liquid chromatography (HPLC). Chromatographic separation was achieved on a C₁₈ column using an acetonitrile–aqueous phosphate buffer (20:80, v/v) elution, buffer being 10 mM disodium hydrogen phosphate brought to pH 7.1 with sodium hydroxide (0.1 N). Validation steps involved measurement of selectivity, accuracy, and precision under conditions of repeatability, reproducibility, sensitivity, and robustness. The lower limit of quantification was 10μg/mL. The validated method has been demonstrated to be reliable for the determination of ranitidine HCl and its related compound C. Stress degradation studies included exposing ranitidine HCl powder and Zantac syrup to acid, alkali, oxidation, and accelerated temperature of 50 °C for 24 hrs and photolysis for 8 hrs. The peaks of degraded products were well resolved from the drug peak. The validation of this method indicated that it could be effectively used to monitor the stability of ranitidine HCl syrup.

Key words: :

• Ranitidine hydrochloride
• Stability
• HPLC
• Stress degradation
• Assay
• Validation

Notes

[10] United States Pharmacopeia (USP) 28-NF 23. Monograph for Ranitidine Hydrochloride; 1702

[12] FDA Center for Drug Evaluation and Research (CDER) Reviewer Guidance, Validation of chromatographic methods, November 1994

[14] ICH, Q1AR2, Stability testing of new drug substances and products, November 2003