Abstract

Purpose: In this present work a simple, rapid, specific and highly sensitive spectrofluorimetric method was developed and validated for the quantification of tapentadol HCl bulk drug and pharmaceutical dosage forms and proposed method was also applied to study of forced degradation and in-vitro dissolution studies. Materials and Methods: The fluorescence intensity of tapentadol HCl in distilled water was measured at emission wavelength 592 nm after excitation at 272 nm by using a Shimadzu (Japan) RF-5301 PC spectrofluorophotometer. A linear relationship was found between fluorescence intensity and concentration in the range of 1-6 µg/mL with a good correlation coefficient – 0.999. Results: The detection and quantification limits were found to be 23.01 and 76.72 ng/mL, respectively. The proposed method was applied for quantification of tapentadol HCl in tablets, with percentage recovery of 99.95–101.45% and percentage RSD values were found to be less than 2 for accuracy and precision studies. Statistical analysis of the results revealed high accuracy and good precision. Conclusion: The suggested procedures could be used for the determination of tapentadol HCl in drug substance and drug products as well as in presence of its degradation products.