Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Determination of Active Pharmaceutical Ingredients in Saridon Tablets Using an Economical and Sensitive TLC Method Combined with Densitometry

Version 1 : Received: 29 November 2023 / Approved: 30 November 2023 / Online: 30 November 2023 (04:08:14 CET)

A peer-reviewed article of this Preprint also exists.

Pyka-Pająk, A. Determination of the Active Pharmaceutical Ingredients in Saridon Tablets Using an Economical and Sensitive Thin Layer Chromatography Method Combined with Densitometry. Analytica 2024, 5, 1-16. Pyka-Pająk, A. Determination of the Active Pharmaceutical Ingredients in Saridon Tablets Using an Economical and Sensitive Thin Layer Chromatography Method Combined with Densitometry. Analytica 2024, 5, 1-16.

Abstract

New TLC-densitometric method have been developed for the identification and quantification of paracetamol (PA), propyphenazone (PP) and caffeine (C) of Saridon tablets using the NP-TLC technique combined with densitometry. This method allows for the simultaneous determination of PA, PP, and C in the same sample. Among all tested chromatographic conditions, the mixture consisting of chloroform + toluene + ethyl acetate + ethanol + acetic acid (18:18:7.5:5.0:0.3, v/v) and silica gel 60F254 plate proved to be the most effective for the separation of three tested active pharmaceutical ingredients (APIs) and substances related to paracetamol. The fully validation of the proposed NP-TLC method proves that it is specific, precise, accurate, robust and sensitive. The percentage content in relation to the content declared by the manufacturer is for propyphenazone 99.8%, paracetamol 101.6% and caffeine 100.8%, which are in accordance with pharmacopoeial requirements. The results presented indicate the possibility of using the developed method in the routine control of pharmaceutical preparations containing these APIs. The proposed method is economical and more sensitive compared to the previously proposed planar methods for the simultaneously determination of PA, PP and CAPIs. Will be an What is more, the presented method may be anaxcellent excellent economical alternative when HPLC method is unavailable for such determination.

Keywords

APIs; Saridon; normal phase thin layer chromatography; densitometry

Subject

Medicine and Pharmacology, Pharmacy

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