ファーマシューティカ アナリティカ アクタ

概要

Stability-Indicating HPLC Assay and Stability Study Over Two Years of Morphine Hydrochloride Diluted Solutions in Polypropylene Syringes

d’Hayer B, Vieillard V, Astier A and Paul M

In the context of a clinical trial involving the production of a hospital preparation, the stability of a solution of morphine hydrochloride diluted in normal saline solution at a concentration of 0.33 mg/mL and contained in polypropylene syringes of 3 mL was studied over a period of two years. Three batches of syringes were manufactured and stored away from light at +5°C at +22°C, and in a climatic chamber at +40°C with 75% relative humidity. The development of a stability-indicating assay of morphine hydrochloride by an ion-pair reversed-phase polarity high performance liquid chromatography, the measurement of pH and osmolality, and the macroscopic and microscopic observation of the solutions were used to assess the stability of the samples. Chemical and physical stability studies have shown that solutions of morphine hydrochloride diluted in 0.9% NaCl at a concentration of 0.33 mg/mL in polypropylene syringes are stable up to two years when syringes are stored away from light at +5°C or at +22°C.