Stability and compatibility of the mixture of tramadol, ketorolac, metoclopramide and ranitidine in a solution for intravenous perfusion

Cabrera, Jesús Hernández; Mancuso, Monique; Cabrera-Fránquiz, F.; Limiñana, J.M.; Díez, A. Blanco

doi:10.1016/s2173-5085(11)70013-2

Cited by 9 publications

(9 citation statements)

References 13 publications

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“…2) are analgesic drugs commonly used in combination in post-operative pain management [1]. Tramadol HCl is a synthetic, centrally acting analgesic with no anti-inflammatory activity and one of the most interesting and useful weak opioids for treatment of moderate to moderately severe pain with weak μ-receptor agonist properties and noradrenergic and serotonergic neurotransmission effects [2][3][4][5][6][7][8].…”

Section: Introductionmentioning

confidence: 99%

A New Rp-HPLC Method Development and Validation for the Simultaneous Estimation of Ketorolac Tromethamine and Tramadol Hydrochloride in Pharmaceutical Dosage Forms.

Y¹,

Kamatham²,

Raju³

et al. 2017

Asian J Pharm Clin Res

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Objective: This study was embarked upon to develop a new, simple, rapid, validated reversed-phase high-performance liquid chromatography (HPLC) method for the estimation of ketorolac tromethamine (KET) and tramadol hydrochloride (TDL) in pharmaceutical dosage forms. Methods:The HPLC method was developed on Shishiedo C18 column (250 mm × 4.6 mm i.d, 5 µ) using methanol: 50 mM phosphate buffer (pH 6.0) in the ratio of 52:48 at 282 nm.Results: Retention time for the drugs was found to be 5.1 and 6.9 minutes for tramadol and ketorolac, respectively. The limit of detection for tramadol and ketorolac were found to be 1.0 and 0.1 µg/ml, limit of quantitation for tramadol and ketorolac were found to be 5.0 and 0.5 µg/ml, respectively. Linearity was established in the range of 20.0-30.0 µg/ml and 8.0-12.0 µg/ml for TDL and KET, respectively. The method was precise with % relative standard deviation <2 for both intra-and interday precision. The accuracy of the method was performed over three levels of concentration, and the recovery was in the range of 98-102%. Conclusion:From the found experimental data, it can be concluded that the developed method is accurate, precise, and selective and can be employed successfully for the estimation of KET and TDL in Pharmaceutical dosage forms.

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Section: Introductionmentioning

confidence: 99%

A New Rp-HPLC Method Development and Validation for the Simultaneous Estimation of Ketorolac Tromethamine and Tramadol Hydrochloride in Pharmaceutical Dosage Forms.

Y¹,

Kamatham²,

Raju³

et al. 2017

Asian J Pharm Clin Res

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“…[ 2 ] Tramadol HCl is a synthetic, centrally acting analgesic with no anti-inflammatory activity and one of the most interesting and useful weak opioids for treatment of moderate to moderately severe pain with weak μ -receptor agonist properties and noradrenergic and serotonergic neurotransmission effects. [ 3 – 9 ]…”

Section: Introductionmentioning

confidence: 99%

“…Ketorolac tromethamine is a potent nonsteroidal anti-inflammatory drug (NSAID) with analgesic efficacy similar to opioids. [ 2 8 – 9 ] This drug is administered to treat moderate pain or, combined with reduced opioid doses, for severe pain. [ 10 ] According to some studies, metoclopramide HCl as an adjuvant agent can improve analgesia and decrease the need for other pain drugs; it is a dopamine and 5-HT receptor antagonist, commonly used as a prokinetic and antiemetic.…”

Section: Introductionmentioning

confidence: 99%

“…Also, this has been recently investigated as an agent that can enhance the efficacy of analgesic drugs. [ 9 11 – 13 ] Some studies have also suggested a role of magnesium sulfate (MgSO 4 ) as an adjuvant agent, an N -methyl- D -aspartate receptor antagonist, in the management of postoperative pain. The perioperative administration of IV MgSO 4 is associated with smaller analgesic requirements, and magnesium sulfate could be of interest as an adjuvant to postoperative analgesia.…”

Section: Introductionmentioning

confidence: 99%

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Chemical stability of tramadol hydrochloride injection admixed with selected pain drugs

Stefano

Pitonzo

Bavetta

et al. 2011

Int J Pharma Investig

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Background:Tramadol hydrochloride (HCl) and ketorolac tromethamine are analgesic drugs, which are commonly used in combination in postoperative pain management. According to some studies, metoclopramide and magnesium sulfate (MgSO4) as adjuvant agents can improve analgesia and decrease the need for other pain drugs.Materials and Methods:The chemical stability of tramadol HCl combined with ketorolac tromethamine and metoclopramide HCl has been studied using a stability-indicating high-performance liquid chromatographic assay method. Calibration curves were produced using linear regression of the peak area against concentration of each drug, with an r2 value ≥ 0.96. Our aim was to investigate the stability of admixture solution of tramadol HCl combined with ketorolac tromethamine and metoclopramide HCl for 48 h (25°C) and 5 days (5°C), with MgSO4, which has never been assessed.Results:Data obtained for admixtures prepared and stored at temperatures of 25°C and 5°C, show that all drugs have reached at least 98% of the initial concentration.Conclusions:For the purpose of pre-preparing drug admixtures to use with confidence, tramadol HCl infusions may be prepared in advance and then thawed before use in clinical units. On the basis of our results, the intravenous mixture of tramadol (7.69 mg/mL), metoclopramide (0.19 mg/mL), ketorolac (1.15 mg/mL), and magnesium sulfate (77 mg/mL) may be considered for a possible commercial formulation.

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“…Tramadol HCl is a synthetic, centrally acting analgesic with no anti-inflammatory activity and one of the most interesting and useful weak opioids for treatment of moderate to moderately severe pain with weak μ-receptor agonist properties and noradrenergic and serotonergic neurotransmission effects 4,5,6,7,8,9,10,11 .…”

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confidence: 99%

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2018

10.13040/IJPSR.0975-8232.9(9).3852-57

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Objective: Simple, rapid, sensitive, precise and reproducible specific UV spectrophotometric method for the determination of Aceclofenac (ACE) and Tramadol (TRM) in bulk drug and pharmaceutical dosage form were developed and validated. Methods: A simple double beam UV spectrophotometric method has been developed and validated with different parameters such as linearity, precision, repeatability, limit of detection (LOD), Limit of Quantification (LOQ), accuracy as per ICH guidelines. Results: UV-visible spectrophotometric method, measurement of absorption at maximum wavelength in 10 ml methanol and volume make with water solvent system as reference ACE and TRM were found to be at 203 nm and 241 nm respectively. The drug obeyed the Beer's law and showed good correlation. Beer's law was obeyed in concentration range 5 -25 µg/ml for ACE and 2 -10 µg/ml for TRM respectively with correlation coefficient was 0.999. The LOD and LOQ of ACE were found to be 4.7862 μg/ml and 14.50 μg/ml, TRM were found to be 2.0518 μg/ml and 6.2176 μg/ml, respectively. Percentage assay of ACE and TRM in tablets. Conclusion:The proposed method is simple, precise, accurate and reproducible can be used for routine analysis of ACE and TRM in bulk and tablet dosage form.

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Stability and compatibility of the mixture of tramadol, ketorolac, metoclopramide and ranitidine in a solution for intravenous perfusion

Cited by 9 publications

References 13 publications

A New Rp-HPLC Method Development and Validation for the Simultaneous Estimation of Ketorolac Tromethamine and Tramadol Hydrochloride in Pharmaceutical Dosage Forms.

A New Rp-HPLC Method Development and Validation for the Simultaneous Estimation of Ketorolac Tromethamine and Tramadol Hydrochloride in Pharmaceutical Dosage Forms.

Chemical stability of tramadol hydrochloride injection admixed with selected pain drugs

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