Quick and precise RP-HPLC method development for Tapentadol hydrochloride (original) (raw)
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Quantitative Estimation of Tapentadol Hydrochloride in Human Plasma by HPLC
2015
A simple, rapid, selective, sensitive, accurate and precise High Performance Liquid Chromatography (HPLC) with UV detection method has been developed and validated for determination of Tapentadol hydrochloride in human plasma. The chromatographic separation of Tapentadol hydrochloride was achieved with Chromasil C18 column using a mobile phase Methanol: water (60:40 v/v) at flow rate 1.0 ml/min. Plasma samples were processed using acetonitrile as precipitating agent to extract drug. The linearity for Tapentadol hydrochloride was found to be 100-1000 ng/ml with regression coefficient (r 2 ) 0.9980. The limit of quantification in plasma for Tapentadol hydrochloride was found to be 100 ng/ml. The mean recovery was obtained at 85.20 %. The method has been used to perform pharmacokinetic and bioequivalence studies in human plasma.
2021
Objective: Tapentadol Hydrochloride was approved (November 2008) by the United States Food and Drug Administration for the relief of moderate to severe pain. It is an opioid analgesic, acts by dual mechanism as opioid receptor agonist and norepinephrine reuptake inhibitor. The present research work was aimed to develop an accurate, precise, and rapid RP-HPLC method and subsequently validates the method according to the International Conference on Harmonization (ICH) guidelines for the determination of Tapentadol Hydrochloride. Methods: Tapentadol Hydrochloride was analyzed by using High-Performance Liquid Chromatography. Better separation of the drug was achieved by using a Symmetry C18 column (150x4.6mm, 3.5μm) with the mobile phase consisted of a mixture of Orthophosphoric acid (0.1% of Orthophosphoric acid in HPLC water) and acetonitrile in the ratio of 30:70 v/v at a flow rate of 1 Original Research Article Sangeetha et al.; JPRI, 33(11): 7-16, 2021; Article no.JPRI.66200 8 ml/m...
Journal of Applied Pharmaceutical Science
An Liquid chromatography tandem mass spectrometry (LC-MS/MS) technique is one of the best analytical methods for the quantification of drugs in biological samples. A stability-indicating analytical technique was developed for the quantitation of tapentadol in biological matrices as tapentadol with short runtime. Developed technique also suitable for bioavailability studies in healthy rabbits. Separation of tapentadol and tapentadol-d3 were achieved from plasma sample with solid-phase extraction and elution was processed with Luna-C 18 (5 μ, 100 mm × 4.6 mm) stationary column with movable phase ratio comprising 2-mM ammonium acetate buffer (pH-3.6) and acetonitrile in the proportion of 10:90 % V/V. Quantitation was processed by processing the transitions of tapentadol and tapentadol-d3 at m/z 222.2 → 177.1 and 228.2 → 183.1, respectively, in positive ionization mode. Linearity was performed over the concentration range of 0.121 to 35.637 mg/ml (R 2 > 0.99) without matrix effect (2.74%). The inter-and intra-day precision findings were within 8.62% and 11.38%, respectively. Stability data showed that the tapentadol was stable when it exposed to different stability conditions. This technique was effectively applied to bioavailability studies of tapentadol in healthy rabbits.
2013
The purpose of the research described herein was to develop simple, precise and accurate isocratic stability indicating reversed phase HPLC assay method for determination of Tapentadol solid dosage forms. Isocratic RP-HPLC method was developed on Phenomenex Luna C8 150 4.6mm, 5μm column using mobile phase as methanol - 0.002 M potassium dihydrogen phosphate buffer pH 3.0 (60: 40 v/v) at a flow rate of 1.0 ml/min and the detection was carried out at 272 nm using photo-diode array detector. The drug was subjected to oxidation, hydrolysis, photolysis and heat to apply stress condition. The validation element investigated showed that the method has acceptable specificity, accuracy, linearity, solution stability, precision and robustness.
International Journal of Chemical and Analytical Science, 2013
A new simple, specific, precise and accurate reversed-phase liquid chromatography method has been developed for simultaneous estimation of Drotaverine HCl (DRO) and Nimesulide (NIM) in tablet formulation. The separation was achieved on a 5-micron C18 column (250 X 4.6 mm) using mobile phase consisting of a mixture of water: acetonitrile: methanol 30: 35: 35 % (pH 2.5, adjusted with orthophosphoric acid). The flow rate was maintained at 1.0 ml/min, with an average operating pressure of 2630 psi. The detection of the constituents was done using UV detector at 295 nm for DRO and NIM. The retention time of DRO and NIM were approximately 5.6 and 10.6 min respectively. Recovery study values of DRO and NIM is 100.06+0.40 and 100.13+0.34 respectively, relative standard deviation of less than 2% for the assay show that the method is precise, accurate and linear in the concentration given and demonstrate the method developed is rugged and robust. Linear response obtained for DRO was in the concentration range 50-250 µg/ml and NIM in the range 125-625 µg/ml.
Determination of tapentadol and tapentadol-O-glucuronide in human serum samples by UPLC-MS/MS
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2015
Tapentadol is a novel, centrally acting analgesic with 2 mechanisms of action, MOR agonism and noradrenaline (NA) reuptake inhibition in a single molecule. It is the first member of a new therapeutic class, MOR-NRI. A high throughput liquid chromatography-tandem mass spectrometric (LC-MS/MS) assay was developed and validated for the quantitative analysis of tapentadol and its O-glucuronide metabolite in human serum. Simultaneous quantification was deemed to be challenging because of the large difference in concentrations between tapentadol and its O-glucuronide metabolite in clinical samples. Therefore, a method was established using a common processed sample, but with different injection volumes and chromatographic conditions for each analyte. Tapentadol and tapentadol-O-glucuronide were determined by protein precipitation of 0.100ml of the samples with acetonitrile. The internal standards used are D6-tapentadol and D6-tapentadol-O-glucuronide. The validated concentration range was...
2012
A sensitive, specific, precise and linear reverse phase HPLC method was developed for the analysis of related substances in Tapentadol in bulk and pharmaceutical dosage form. The known related substances are methoxy impurity [(2R, 3R)-3-(3-methoxyphenyl)-N,N,2-tri methyl pentanamine] and alcohol impurity [(2S)-1dimethylamino)-3-(3-methoxyphenyl)-2-methylpentan-3-ol hydrochloride]. The method was carried out on a Zodiac C18 column (250 mm x 4.6 mm; 5μ) using a mobile phase mixture of phosphate buffer pH 7.0, acetonitrile and methanol in a gradient elution at a flow rate of 1.0ml/min at wavelength of 220 nm. The retention time of tapentadol was found to be 14±0.1 min, methoxy impurity was found to be 39.75±0.1 min and alcohol impurity was found to be 30.9±0.1min. The method can be used for the detection and quantitative estimation of known and unknown impurities in drug and pharmaceutical dosage form.
Journal of analytical toxicology, 2018
Tapentadol is a centrally acting synthetic analgesic which is prescribed for the treatment of a range of chronic pain conditions. Its use in treating various pain conditions is increasing and, as with other opioids, it has the potential to be abused. We describe a three-stage incorporation of tapentadol into validated screening and quantitative methods through: (i) addition of retention time/mass spectral data to a database, (ii) qualitative validation and (iii) quantitative validation. This represents an efficient and flexible approach to the incorporation of new compounds of interest to existing screening methods. Tapentadol was analyzed in blood and serum samples using alkaline liquid-liquid extraction with identification and quantitation by liquid chromatography/time-of-flight mass spectrometry. In a series of six post-mortem cases where tapentadol was detected but was not a primary causative factor in death, blood concentrations ranged from 0.01 to 1.0 mg/L. In two cases where ...
Journal of Global Trends in Pharmaceutical Sciences, 2015
At present, simultaneous determination of drugs in the combination dosage forms has been enjoying renaissance in the field of pharmaceutical analysis. Tapentadol is a centrally-acting Opioid analgesic that readily crosses the blood-brain barrier, and. Paracetamol, is an effective classical antipyretic drug. From the reviewed literature, simultaneous UV spectrophotometric methods have not yet been developed for the quantification of Tapentadol and Paracetamol. So the present study involves the simultaneous quantitation of Tapentadol and Paracetamol in tablet dosage form by UV Spectrophotometer. The λmax of Tapentadol was 239 nm and Paracetamol was 265 in 0.1N NaOH. The correlation coefficients for both Tapentadol and Paracetamol were found to be 0.999. The precision of the method was confirmed by intra-day and inter-day analysis. The % RSD values of intra-day and inter-day analysis were found to be 0.1261 and 0.34135