Stability of ranitidine syrup repackaged in unit-dose containers

摘要

Purpose. The stability of ranitidine syrup repackaged in unit-dose containers was studied.rnMethods. Oral ranitidine hydrochloride syrup containing 16.8 mg/mL of ranitidine hydrochloride (equivalent to 15 mg of ranitidine) in original bulk containers and repackaged in unit-dose amber-colored glass bottles sealed with aluminum caps were obtained from commercial sources. For extended-stability determinations, samples were stored for 52 weeks at 25℃ and 40% relative humidity and analyzed at 0, 4, 13, 26, 39, and 52 weeks. For accelerated stability determinations, samples were stored for 13 weeks at 40℃ and 25% relative humidity and analyzed at 0, 4, 9, and 13 weeks. Stability was assessed using high-performance liquid chromatography and by measuring changes in pH and sample weight. The principal impurity and total impurities were also measured. Results. No significant changes in pH were demonstrated, and all values remainedrnwell within acceptable limits. The weight change in samples was greater for repackaged samples stored in accelerated conditions compared with that of samples in the original packaging; however, the differences were not significant. Ranitidine hydrochloride samples in both types of packaging remained stable when stored at 25 ℃ and 40% relative humidity for 52 weeks and at 40 ℃ and 25% relative humidity for 13 weeks. The impurity profiles remained within acceptable limits for all samples. Conclusion. Repackaged ranitidine syrup was stable for up to 52 weeks when stored at 25 ℃ and 40% relative humidity and for up to 13 weeks when stored at 40 ℃ and 25% relative humidity.