Volume No. :   4

Issue No. :  6

Year :  2012

ISSN Print :  0975-234X

ISSN Online :  0975-4377


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Development and Validation of visible Spectrophotometric method of Tapentadol Hydrochloride in bulk and Pharmaceutical dosage form



Address:   Madhu Babu K., Kathirvel S.*
Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur, Andhra Pradesh – 522002
*Corresponding Author
DOI No:

ABSTRACT:
A simple, sensitive, accurate spectrophotometric method has been developed for the estimation of Tapentadol hydrochloride in bulk and pharmaceutical formulation. The method is based on the formation of blue colored chromogen with Folin-Ciocalteu reagent in the presence of NaOH and obeys beer’s law in the range of 5 - 35µg/mL exhibiting the maximum absorbance at 763nm. The limit of detection and quantification were found to be 0.76µg/mL and 2.33µg/mL respectively. The calibration curve demonstrated a linear relationship between the absorbance and concentration, with the correlation coefficient higher than 0.9999. The Regression Equation of the curve was Y=0.0248x-0.0436. The method was fully validated according to ICH guidelines.
KEYWORDS:
Tapentadol hydrochloride, Folin-Ciocalteu (FC) reagent, NaOH, Validation, ICH guidelines.
Cite:
Madhu Babu K., Kathirvel S. Development and Validation of visible Spectrophotometric method of Tapentadol Hydrochloride in bulk and Pharmaceutical dosage form. Research J. Pharma. Dosage Forms and Tech. 2012; 4(6): 328-331.
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