RP-HPLC Method Development and Validation for the Estimation of Tapentadol Hydrochloride in Marketed Tablet dosage form

Dr Kumar Raja Jayavarapu , Dr D Praveen Kumar , G Ruchitha

Tapentadol hydro- chloride, correlation coefficient, reproducibility.

Objective: To develop a simple, novel, sensitive, precise and specific RP-HPLC method for the determination of Tapentadol hydrochloride in bulk and its tablet dosage forms. Methods: The chromatographic separation was achieved on C18 Licrosphere column (150 mm to 4.6 mm inner diameter, 5 mm particle size) as a stationary phase using Methanol: 0.1 mM Dipotassium Phosphate buffer (pH 4, adjusted with ortho phosphoric acid) as mobile phase at detection wavelength 280 nm in isocratic mode at a flow rate of 1 ml/min. Results: The calibration curve for Tapentadol hydrochloride was linear from 75 to 450 mg/ml. The correlation coefficient (r2 ) value was found to be 0.9994. Precision study showed % CV value less than 2% in all selected concentrations. The % recoveries of Tapentadol hydro- chloride are in the range of 99.96e100.01%. The limit of detection and limit of quantification for Tapentadol hydrochloride were found to be 0.25 mg/ml and 0.75 mg/ml respectively. Conclusion: The developed method has good sensitivity, reproducibility and specificity for the determination of Tapentadol hydrochloride in bulk and its tablet dosage forms. This method was simple, fast, accurate, and precise. Hence this method was validated and found to be suitable for determining the purity of Tapentadol hydrochloride in bulk drugs and pharmaceutical formulations. The proposed validated method was successfully used for the quantitative analysis of commercially available dosage form.

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"RP-HPLC Method Development and Validation for the Estimation of Tapentadol Hydrochloride in Marketed Tablet dosage form", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.9, Issue 10, page no.c448-c461, October-2024, Available :https://ijnrd.org/papers/IJNRD2410255.pdf

Volume 9 Issue 10, October-2024

Pages : c448-c461

Paper Reg. ID: IJNRD_301526

Published Paper Id: IJNRD2410255

Downloads: 00023

Research Area: Pharmacy All

Country: Sathupally, Telangana, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2410255

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2410255

ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016

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Publisher: IJNRD (IJ Publication) Janvi Wave

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