Quick and precise RP-HPLC method development for Tapentadol hydrochloride

Bishnoi, Mamta; Jain, Ankit; Singla, Yashpaul; Shrivastava, Birendra

doi:10.31024/ajpp.2019.5.5.19

Cited by 3 publications

(3 citation statements)

References 10 publications

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“…LOD and LOQ were calculated at 3.33 and 10 µg/mL. Stability was calculated by taking percent ratio of the determined 80, 100, and 120 µg/mL concentrations after 6 h, 3 days, and 7days period which was found satisfactory as shown in Table 5 2,13 .…”

Section: Fig 3: Linearly Regressed Calibration Curve Of Tap In Distimentioning

confidence: 98%

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2020

IJPSR

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The objective was to develop and validate an easy, economical, fast, reliable, reproducible, precise and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method for the estimation of tapentadol hydrochloride (TAP, a mu opioid-receptor agonist, and noradrenaline reuptake inhibitor) in the bulk and pharmaceutical dosage form. The chromatographic separation was achieved by using the HPLC system equipped with a C-18(2) column (250 × 4.6 mm, Particle size 5µm) at wavelength 217 nm. The mobile phase consisting of Potassium phosphate buffer: Acetonitrile (50:50 v/v) was used in isocratic mode. The flow rate was fixed at 1.0 mL/min with a continuous run up to 5 min, while the retention time was located near about 2.5 min. In the concentration range of 60-160 µgmL-1 , the detector response was found linear with linear regressed equation Y=22791X+120122. In the assay of TAP, 99.65% of the drug was recovered. This method proved a satisfactory validation for all the parameters such as accuracy, linearity, specificity, precision, range, ruggedness, robustness, reproducibility, and peak purity assessment as per ICH guidelines. The results of the study evidenced that it is useful for the routine determination of tapentadol in the bulk and pharmaceutical dosage forms like a tablet.

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Section: Fig 3: Linearly Regressed Calibration Curve Of Tap In Distimentioning

confidence: 98%

“…)-3-(dimethylamino)-1-ethyl-2-methyl]-propylphenol hydrochloride (TAP), the first US FDA-approved centrally acting analgesic for the treatment of moderate to severe acute pain 1,2 .…”

Section: Introduction: Tapentadol 3-[(1r2rmentioning

confidence: 99%

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2020

IJPSR

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“…A review of the analytical techniques described in the literature for evaluating Tap includes spectrophotometric methods such as first-order (228 nm) and second-order (235 nm) derivative methods (5) , UV and visible (Folin-ciocalteu reagent) analysis methods (6) , zero crossing at 242nm and 272nm (7) , UV at 271nm (8,9), In the study (10) , several methods were used, including UV light at 273.3 nm, Folin-Ciocalteu light at 494.6 nm, Orange-Red diazotize complex light at 414.6 nm, and ion pair with bromothymol Blue in Chloroform at 773.3 nm were all used. In addition, several chromatographic methods and techniques have been used to determine Tap in its pure form and for pharmaceutical doses, including HPLC with photodiode array detector (11) , HPLC with electrochemical detection (12) , RP-HPLC method (13,14) , HPTLC analysis (15) , LC-MS/MS technique (16) and RP-UFLC method (17) . In addition, the simultaneous determination of Tap includes Tap with aripiprazole (18) , Tap with paracetamol using two different first-order derivative methods (19) and a Q-spectrophotometric approach (20) and a nanographenemodified electrode as an electrochemical sensor.…”

Section: Sketch 1:the Chemical Structure Of Tapentadolmentioning

confidence: 99%

Kinetic Spectrophotometric Determination of Tapentadol

N. DNBEEL,

Z. AL ABDALI,

S. OMER

et al. 2023

MINAR Journal

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A simple, inexpensive, accurate and sensitive spectrophotometric method and kinetic assay have been established to determine tapentadol in pure form, tablets and urine samples. The method is based on the reaction of tapentadol with ferric ions in an acidic solution in the presence of ferricyanide to give water-soluble Prussian blue dye with a maximum absorption wavelength of 735 nm, with a maximum reaction time of 40 minutes. Several experimental factors affect the colour intensity and stability time approaches. The reaction was identified as a first-order pseudo-reaction by calculating the initial rate, and the results of the fixedtime method (at 30 min) are more suitable for quantification and used to construct the calibration curves. The correlation between concentration and absorbance was linear. Moreover, varies from 2 to 12 μg/mL and has a detection limit of 0.1737 μg/mL and a quantification limit of 0.5264 μg/mL. The molar absorption coefficient and Sandel sensitivity were 1.5484 x 10 4 L.mol-1.cm-1 and 0.01430 μg.cm-2, respectively. A comparison of spectrophotometric data with a well-established fixed time kinetic demonstrated that the fixed time technique offers good accuracy, precision, low detection and quantification limitations, and is time efficient. These procedures were effectively used to analyze tapentadol in its pure form, tablet form, and urine sample, which were not observed in literature before

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HPTLC Analysis and Force Degradation Study of Tapentadol Hydrochloride in Bulk and Its Pharmaceutical Formulation

Asmita

Mahaveer

Sagar

et al. 2022

RJPT

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To achieve easy, sensitive reproducible high-performance thin-layer chromatography (HPTLC) densitometric method was developed and validated for the determination of tapentadol HCl and its pharmaceutical formulation. In this method the ethyl acetate: methanol: ammonia (6:4:0.5v/v/v) were used as mobile phase for chromatographic separation of the drug. The method has been performed on precoated silica Tab 60F254 Merck plates and the Rf value was calculated at 0.47 for tapentadol HCL. The calibration curve was plotted in the concentration range of 500-2500ng/ml. The limits of quantitation and limit of detection were found to be 0.07 and 0.23μg/ml respectively. The correlation coefficient (R2) value was obtained at 0.998 for tapentadol HCL. The percent recoveries were obtained between 99.97 to 101.13% for tapentadol HCl. The method has been validated according to ICH guidelines for linearity, precision, accuracy, specificity, and robustness. The degradation behavior was recorded under acidic, basic, neutral, oxidative, photolytic, and thermal stress conditions. The degradation products were well separated from the pure drug under the optimized conditions. As the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating method for tapentadol HCl.

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Quick and precise RP-HPLC method development for Tapentadol hydrochloride

Cited by 3 publications

References 10 publications

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Kinetic Spectrophotometric Determination of Tapentadol

HPTLC Analysis and Force Degradation Study of Tapentadol Hydrochloride in Bulk and Its Pharmaceutical Formulation

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