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Stability‐indicating HPLC assays for the determination of piritramide and droperidol in PCA solution
Author(s) -
Selbach S.,
Diederich W. E.,
Fett S.,
Fründ D.,
Koch T.,
Eberhart L. H. J.
Publication year - 2011
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/j.1365-2710.2010.01169.x
Subject(s) - droperidol , chromatography , chemistry , high performance liquid chromatography , anesthesia , vomiting , medicine
Summary What is known and Objective: A mixture of morphine and droperidol is a well‐established antiemetic for reducing the risk of postoperative nausea and vomiting. A mixture of piritramide and droperidol has not yet been evaluated in this context. Our objectives were to develop a high‐performance liquid chromatographic assay for piritramide and droperidol in 0·9% saline, and to establish their stability under defined storage conditions. Methods: The separation and assay of both drugs were attempted by high performance liquid chromatography (HPLC) using a RP‐select B column and a mobile phase of 57:43% v/v methanol‐monosodium phosphate solution 0·05 M at a flow rate of 1·2 mL/min. UV detection at 205 and 246 nm for piritramide and droperidol were used, respectively. Results and Discussion: The HPLC method was successful. Linearity was shown for piritramide from 0·075 to 0·013 mg/mL and for droperidol from 0·8 to 0·2 mg/mL. The intra‐ and inter‐day relative standard deviation (RSD, %) was 0·27% and 0·54% for piritramide and droperidol, respectively. The two drugs were stable for at least 72 h when stored under ambient light at room temperature. What is new and Conclusion: Seventy‐five milligrams piritramide and 2·5 mg droperidol diluted to 50 ml with 0·9% saline should be suitable for clinical use. At this dilution, a Dipidolor ® and Xomolix ® , mixture, was stable when stored under ambient light exposure at room temperature for at least 72 h.