title: Stability of Metronidazole Suspensions.
abstract: Metronidazole is an antiprotozoal agent used in the treatment of bacterial and protozoal anaerobic infections. The objectives of this study were to develop concentrated metronidazole suspensions that are inexpensive and easy to prepare and determine the stability of these suspensions after storage in amber polyvinyl chloride bottles at room temperature (23°C) and under refrigeration (5°C). Metronidazole suspensions (50 mg/mL) were prepared from powder using Ora-Blend or simple syrup as the vehicles. Samples were collected in triplicate from each container on days 0, 7, 14, 28, 56, and 93. Samples were assayed using a high-performance liquid chromatography method that had been validated as stability indicating. Color, change in physical appearance, and pH were also monitored at each time interval. There was no apparent change in color or physical appearance. The pH values changed by less than 0.20 units over the 93 days. The stability of metronidazole suspensions compounded from United States Pharmacopeia powder using Ora-Blend or simple syrup and packaged in amber polyvinyl chloride bottles was determined to be 93 days when stored at either room temperature or under refrigeration.
authors.forename: Ronald F
authors.initials: RF
authors.lastname: Donnelly
authors.forename: James
authors.initials: J
authors.lastname: Ying
mesh_terms: D000981:Antiprotozoal Agents / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D003116:Color; D004339:Drug Compounding; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D005079:Excipients / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D008795:Metronidazole / Q000737:chemistry*; D019999:Pharmaceutical Solutions; D011143:Polyvinyl Chloride / Q000737:chemistry; D013678:Technology, Pharmaceutical / Q000379:methods*; D013696:Temperature; D013997:Time Factors
chemical_list: D000981:Antiprotozoal Agents; D005079:Excipients; D019999:Pharmaceutical Solutions; D008795:Metronidazole; D011143:Polyvinyl Chloride