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Long-Term Stability of Tramadol and Ketamine Solutions for Patient-Controlled Analgesia Delivery.

Gu J, Qin W, Chen F, Xia Z - Med. Sci. Monit. (2015)

Bottom Line: No changes in color or turbidity were observed in any of the prepared solutions.Throughout this period, pH values remained stable.The results indicate that the drug mixtures of tramadol with ketamine in NS for PCA delivery systems were stable for 14 days when stored in polyolefin bags at 4°C or 25°C.

View Article: PubMed Central - PubMed

Affiliation: Department of Anesthesiology, enmin Hospital of Wuhan University, Wuhan, Hubei, China (mainland).

ABSTRACT

Background: Subanesthetic doses of ketamine as an adjuvant to tramadol in patient-controlled analgesia (PCA) for postoperative pain have been shown to improve the quality of analgesia. However, there are no such commercially available drug mixtures, and the stability of the combination has rarely been assessed.

Material and methods: Admixtures were assessed for periods of up to 14 days at 4°C and 25°C. Three different mixtures of tramadol and ketamine (tramadol 5.0 mg/mL + ketamine 0.5 mg/mL, tramadol 5.0 mg/mL + ketamine 1.0 mg/mL, and tramadol 5.0 mg/mL + ketamine 2.0 mg/mL) were prepared in polyolefin bags by combining these 2 drugs with 0.9% sodium chloride (normal saline [NS]). The chemical stability of the admixtures was evaluated by a validated high-performance liquid chromatography (HPLC) method and by measurement of pH values. Solution appearance and color were assessed by observing the samples against black and white backgrounds. Solutions were considered stable if they maintained 90% of the initial concentration of each drug.

Results: The percentages of initial concentration of tramadol and ketamine in the various solutions remained above 98% when stored at 4°C or 25°C over the testing period. No changes in color or turbidity were observed in any of the prepared solutions. Throughout this period, pH values remained stable.

Conclusions: The results indicate that the drug mixtures of tramadol with ketamine in NS for PCA delivery systems were stable for 14 days when stored in polyolefin bags at 4°C or 25°C.

No MeSH data available.


Related in: MedlinePlus

HPLC chromatograms of tramadol-ketamine solutions. a: Freshly prepared sample of tramadol/ketamine solutions. b: Acidified sample of tramadol/ketamine solutions after 5 h at 60°C. c: Alkaline-degraded sample of tramadol/ketamine solutions after 5 h at 60°C. d: Oxidized sample of tramadol/ketamine solutions after 5 h at 60°C. Retention times were 4.6 min for tramadol (peak 1) and 8.1 min for ketamine (peak 2).
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f2-medscimonit-21-2528: HPLC chromatograms of tramadol-ketamine solutions. a: Freshly prepared sample of tramadol/ketamine solutions. b: Acidified sample of tramadol/ketamine solutions after 5 h at 60°C. c: Alkaline-degraded sample of tramadol/ketamine solutions after 5 h at 60°C. d: Oxidized sample of tramadol/ketamine solutions after 5 h at 60°C. Retention times were 4.6 min for tramadol (peak 1) and 8.1 min for ketamine (peak 2).

Mentions: A new, simple, and rapid HPLC method was established for simultaneously determining tramadol hydrochloride and ketamine hydrochloride in analgesic mixture samples used in PCA. Under the current chromatographic conditions, tramadol and ketamine were satisfactorily separated. Chromatograms of the degradation samples are shown in Figure 2, demonstrating that the decomposition products were baseline separated from tramadol and ketamine. Retention times were 4.6 min for tramadol and 8.1 min for ketamine. The linearity of tramadol and ketamine were in the range of 0.05–1.0 mg/mL and 0.01–0.5 mg/mL, respectively, with correlation coefficient more than 0.999. The average linear regression equation was represented as y=10.91x+3.732 for tramadol and y=4.448x+0.29 for ketamine. The intra-day and inter-day variations RSD% at 3 concentrations were all less than 2.5% for both drugs. Recovery values for all cases were between 99.0 and 101.0 with RSD <3.0%. These results indicate that the method provides adequate accuracy and precision for quality control of tramadol and ketamine in NS.


Long-Term Stability of Tramadol and Ketamine Solutions for Patient-Controlled Analgesia Delivery.

Gu J, Qin W, Chen F, Xia Z - Med. Sci. Monit. (2015)

HPLC chromatograms of tramadol-ketamine solutions. a: Freshly prepared sample of tramadol/ketamine solutions. b: Acidified sample of tramadol/ketamine solutions after 5 h at 60°C. c: Alkaline-degraded sample of tramadol/ketamine solutions after 5 h at 60°C. d: Oxidized sample of tramadol/ketamine solutions after 5 h at 60°C. Retention times were 4.6 min for tramadol (peak 1) and 8.1 min for ketamine (peak 2).
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Related In: Results  -  Collection

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getmorefigures.php?uid=PMC4554362&req=5

f2-medscimonit-21-2528: HPLC chromatograms of tramadol-ketamine solutions. a: Freshly prepared sample of tramadol/ketamine solutions. b: Acidified sample of tramadol/ketamine solutions after 5 h at 60°C. c: Alkaline-degraded sample of tramadol/ketamine solutions after 5 h at 60°C. d: Oxidized sample of tramadol/ketamine solutions after 5 h at 60°C. Retention times were 4.6 min for tramadol (peak 1) and 8.1 min for ketamine (peak 2).
Mentions: A new, simple, and rapid HPLC method was established for simultaneously determining tramadol hydrochloride and ketamine hydrochloride in analgesic mixture samples used in PCA. Under the current chromatographic conditions, tramadol and ketamine were satisfactorily separated. Chromatograms of the degradation samples are shown in Figure 2, demonstrating that the decomposition products were baseline separated from tramadol and ketamine. Retention times were 4.6 min for tramadol and 8.1 min for ketamine. The linearity of tramadol and ketamine were in the range of 0.05–1.0 mg/mL and 0.01–0.5 mg/mL, respectively, with correlation coefficient more than 0.999. The average linear regression equation was represented as y=10.91x+3.732 for tramadol and y=4.448x+0.29 for ketamine. The intra-day and inter-day variations RSD% at 3 concentrations were all less than 2.5% for both drugs. Recovery values for all cases were between 99.0 and 101.0 with RSD <3.0%. These results indicate that the method provides adequate accuracy and precision for quality control of tramadol and ketamine in NS.

Bottom Line: No changes in color or turbidity were observed in any of the prepared solutions.Throughout this period, pH values remained stable.The results indicate that the drug mixtures of tramadol with ketamine in NS for PCA delivery systems were stable for 14 days when stored in polyolefin bags at 4°C or 25°C.

View Article: PubMed Central - PubMed

Affiliation: Department of Anesthesiology, enmin Hospital of Wuhan University, Wuhan, Hubei, China (mainland).

ABSTRACT

Background: Subanesthetic doses of ketamine as an adjuvant to tramadol in patient-controlled analgesia (PCA) for postoperative pain have been shown to improve the quality of analgesia. However, there are no such commercially available drug mixtures, and the stability of the combination has rarely been assessed.

Material and methods: Admixtures were assessed for periods of up to 14 days at 4°C and 25°C. Three different mixtures of tramadol and ketamine (tramadol 5.0 mg/mL + ketamine 0.5 mg/mL, tramadol 5.0 mg/mL + ketamine 1.0 mg/mL, and tramadol 5.0 mg/mL + ketamine 2.0 mg/mL) were prepared in polyolefin bags by combining these 2 drugs with 0.9% sodium chloride (normal saline [NS]). The chemical stability of the admixtures was evaluated by a validated high-performance liquid chromatography (HPLC) method and by measurement of pH values. Solution appearance and color were assessed by observing the samples against black and white backgrounds. Solutions were considered stable if they maintained 90% of the initial concentration of each drug.

Results: The percentages of initial concentration of tramadol and ketamine in the various solutions remained above 98% when stored at 4°C or 25°C over the testing period. No changes in color or turbidity were observed in any of the prepared solutions. Throughout this period, pH values remained stable.

Conclusions: The results indicate that the drug mixtures of tramadol with ketamine in NS for PCA delivery systems were stable for 14 days when stored in polyolefin bags at 4°C or 25°C.

No MeSH data available.


Related in: MedlinePlus