Eco-friendly HPTLC Determination of Paracetamol, Caffeine, Drotaverine HCl and Two of their Official Impurities; Application to Assay and Content Uniformity Testing of Tablet Dosage Form

Samia A. Tawfik, Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo, Egypt - 11562Follow
Nariman A. El-Ragehy, Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo, Egypt - 11562
Maha A. Hegazy, Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo, Egypt - 11562
Ghada A. Sedik, Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo, Egypt - 11562

Subject Area

General Chemistry

Abstract

The present work is focused on developing and validating an eco-friendly, sustainable and sensitive HPTLC method for the purpose of simultaneous determination of a five component mixture. This mixture includes paracetamol, caffeine, drotaverine HCl and the official impurities of the first two aforementioned drugs, namely; p-aminophenol and theophylline, in order. The developed method is based on application of planar chromatography using a developing system of ethyl acetate: methanol: acetic acid (8:1:2, by volume). Quantitative determination of the mentioned components was performed using UV detection. The parameters impacting chromatographic separation have been optimized. The cited compounds were effectively separated with retardation factor (Rf) values of 0.82, 0.57, 0.12, 0.45 and 0.66 for paracetamol, caffeine, drotaverine HCl, p-aminophenol and theophylline, respectively. In accordance with the International Council on Harmonisation (ICH) recommendations, method validation was performed, where the suggested method was found to be sensitive, precise and accurate. The National Environmental Method Index (NEMI), Analytical Eco-Scale, and Green Analytical Procedure Index (GAPI) tools were used in order to evaluate and prove the greenness profile of the proposed method. Statistically, there wasn’t any significant difference between the results obtained by the proposed method and those of official or reported ones concerning accuracy and precision. The developed method was effectively employed for the quantitative determination of the cited drugs and two of their official impurities in their pure form, laboratory prepared mixtures and pharmaceutical formulation. Furthermore, content uniformity testing was performed to investigate the uniformity of co-formulated tablets according to the United States Pharmacopeia’s standards.

Recommended Citation

Tawfik, Samia A.; El-Ragehy, Nariman A.; Hegazy, Maha A.; and Sedik, Ghada A. (2024) "Eco-friendly HPTLC Determination of Paracetamol, Caffeine, Drotaverine HCl and Two of their Official Impurities; Application to Assay and Content Uniformity Testing of Tablet Dosage Form," Bulletin of Faculty of Pharmacy Cairo University: Vol. 62 : Iss. 1 , Article 1.
Available at: https://doi.org/10.54634/2090-9101.1048