Development and Validation of Raman Spectrometric Method For Simultaneous Estimation of Paracetamol and Tapentadol Hydrochloride in their Combined Dosage Form

Abstract

The capability of vibrational Raman spectroscopy for the rapid and non-destructive quantitative analysis of multicomponent solid dosage forms was tested. PCM and TAP in combined tablet dosage form were simultaneously determined in the presence of the numerous excipients of the tablets. A Raman calibration model was developed by measuring the peak intensities of different concentration of standard powders of PCM and TAP vibration at 853.54 cm−1 and 991 cm−1, respectively . The assay results obtained were101.7± 2.4 and 98.6 ± 1.9 for PCM and TAP, respectively. The r2 values for PCM and TAP are 0.996 and 0.990 respectively. With the proposed procedure, the Accuracy (%Recovery) for PCM was 98.0 -98.5 % and 98.0 – 100.1 % Recovery for TAP. The reliability of this method was verified by testing it against the conventionally used reported RP-HPLC technique. The assay results obtained were 100.9 ± 0.48 and 99.1± 0.82 for PCM and TAP Respectively. The results from both methods were in excellent agreement. The main advantage of Raman over HPLC method during routine analysis is that is less time consuming, non-destructive, solvent-free, no sample preparation is required. The proposed procedure based on univariate calibration model of Raman spectra can be a fast and convenient alternative to the standard pharmacopoeial methods for simultaneous quantification of both drugs in combined solid dosage forms without any sample preparation or solvent usage.