Simultaneous Determination of Acetaminophen and Synthetic Color(s) by Derivative Spectroscopy in Syrup Formulations and Validation by HPLC: Exposure Risk of Colors to Children

Abstract

Abstract. Color additives are used in pediatric syrup formulations as an excipient; though not prerequisite, but pediatric syrup formulations are normally colored. An attempt has been made to measure simultaneously the single drug, acetaminophen (AT), along with the colors, carmoisine (CA), erythrosine (ET), and sunset yellow FCF (SSY) added in it by three derivative spectroscopy methods namely, 1st order, ratio, and differential derivative methods. Moreover, evaluation has been made for the exposure assessment of the colors added as excipient because some colors have been reported to cause allergic reactions and hypersensitivity in children. The present methods provide simple, accurate, and reproducible quantitative determination of the drug, AT, along with the color in synthetic mixtures and commercial drug formulations without any interference. The limit of detection varied from 0.0001-0.31 μg/ml while limit of quantification ranged from 0.002-1.04 μg/ml in all the three methods. The calibration curve of all the three derivative methods exhibited good linear relationship with excellent regression coefficients (0.9986-1.000). Both intra-day and inter-day precisions showed %RSD value less than 2% while the percentage recovery was found between 96.8-103.8%. The sensitivity of the proposed methods is almost comparable to HPLC and thus, can be used for determination of drug AT, and color simultaneously in pharmaceutical formulation on routine basis. The present methods also showed that colors like SSY and ET are saturating more than 50% of acceptable daily intake (ADI) value which is alarming and needs to be considered for modification by regulatory authorities to safeguard the health of children.

Formulation and evaluation of an Anti-pyretic (Paracetamol) syrup for Paediatric

“…Paracetamol is well tolerated produces few side effects from the gastrointestinal tract, however, despite that, every year, has seen a steadily increasing number of registered cases of Paracetamolinduced liver intoxication all over the world [6].…”

A Characteristic Interval Modeling Method for Simultaneous Detection of Multiple Metal Ions

“…3) The instrument has the advantages of simple structure, low maintenance cost and low repetition rate, and is suitable for on-line analysis ( Attimarad 2012 ; Merás et al, 2002 ). However, due to the coexistence of multiple heavy metal ions in the same period in zinc smelting industrial wastewater, their chemical characteristics are similar, their mutual influence is serious ( Rastogi et al, 2015 ), their absorption spectra overlap seriously ( Lambert et al, 2017 ), and the full spectra information contains a lot of redundant non characteristic information ( Fedenko et al, 2017 ), resulting in low accuracy and large prediction error of ultraviolet visible spectral analysis model ( Lepane et al, 2015 ; Lee et al, 2017 ). Therefore, the traditional multivariate linear analysis method based on full band information modeling is difficult to accurately detect the concentration of polymetallic ions in zinc smelting wastewater ( Rote and Bari, 2009 ; Khan et al, 2020 ).…”

A Nonlinear Integrated Modeling Method of Extended Kalman Filter Based on Adaboost Algorithm

“…In recent years, the commonly used methods for on-line detection of metal ions include potentiometric titration (Attimarad 2012), polarography (Duran Meras et al, 2002), inductively coupled plasma mass spectrometry (Rastogi et al, 2015), ultraviolet visible spectroscopy (Lambert et al, 2017) and laser-induced breakdown spectroscopy (Fedenko et al, 2017). As a conventional quantitative analysis method, ultraviolet visible spectroscopy is widely used in the field of analysis and detection due to its advantages of simplicity, accuracy, rapidity, multifunction and low cost (Lepane et al, 2015;Lee and Oh, 2017).…”