Compatible stability of methylprednisolone sodium succinate and tropisetron in 0.9% sodium chloride injection

Eur J Hosp Pharm. 2020 Mar;27(e1):e58-e62. doi: 10.1136/ejhpharm-2018-001693. Epub 2018 Dec 1.

Abstract

Background: A combination of methylprednisolone sodium succinate and tropisetron hydrochloride is commonly used to treat the nausea and vomiting associated with antineoplastic therapy. The objective of this study was to investigate the stability of tropisetron hydrochloride and methylprednisolone sodium succinate in 0.9% sodium chloride injection for up to 48 hours.

Methods: Commercial solutions of methylprednisolone sodium succinate and tropisetron hydrochloride were obtained and further diluted with 0.9% sodium chloride injection to final concentrations of either 0.4 or 0.8 mg/mL (methylprednisolone sodium succinate) and 0.05 mg/mL (tropisetron). The admixtures were assessed for periods of up to 48 hours after storage at 4°C with protection from light and at 25°C without protection from light. Physical compatibility was determined visually, and the chemical compatibility was measured with high-performance liquid chromatography (HPLC) and by measurement of pH values.

Results: HPLC analysis demonstrated that methylprednisolone sodium succinate and tropisetron hydrochloride in the various solutions were maintained at 97% of the initial concentrations or higher during the testing period. There were no changes observed by physical precipitation or pH in any of the prepared solutions.

Conclusions: Tropisetron hydrochloride injection and methylprednisolone sodium succinate injection in 0.9% sodium chloride injection are stable for up to 48 hours at 4°C and 25°C.

Keywords: compounding; drug manufacturing; drug procurement; drug stability; preparation.

MeSH terms

  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / analysis
  • Anti-Inflammatory Agents / chemistry*
  • Antiemetics / administration & dosage
  • Antiemetics / analysis
  • Antiemetics / chemistry*
  • Chromatography, High Pressure Liquid / methods
  • Drug Incompatibility*
  • Drug Stability
  • Humans
  • Injections
  • Methylprednisolone Hemisuccinate / administration & dosage
  • Methylprednisolone Hemisuccinate / analysis
  • Methylprednisolone Hemisuccinate / chemistry*
  • Saline Solution / administration & dosage
  • Saline Solution / analysis
  • Saline Solution / chemistry*
  • Tropisetron / administration & dosage
  • Tropisetron / analysis
  • Tropisetron / chemistry*

Substances

  • Anti-Inflammatory Agents
  • Antiemetics
  • Saline Solution
  • Methylprednisolone Hemisuccinate
  • Tropisetron