Parabens are widely used as preservatives in pharmaceutical industry to control the microbial bioburden. Methyl-, propyl-, and butyl-parabens are the most commonly used preservatives in many types of liquid and topical formulations. A Fourier transform infrared (FTIR) spectrometer equipped with an attenuated total reflectance (ATR) sample handling accessory was used to quantitatively analyze parabens in pharmaceutical finished products. Paraben was quantified at frequency region of 1,600�1,700 cm-1. The PLS calibration model reveals good correlation between the value of paraben obtained from traditional HPLC analysis and the FTIR predicted value with a coefficient of determination (R2) of >0.96. Furthermore, the classification between finished dosage with and without paraben in their formulation was performed using principal component analysis using the same frequency region used for quantification. The developed method was subsequently used for analysis of commercially available liquid pharmaceutical products. The FTIR-ATR methodology provides a simple means of quantification of parabens in pharmaceutical dosage forms.

Quantitative FTIR analysis of paraben in finished dosage pharmaceuticals

246th National Meeting (2013)

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