Evaluation of Pharmaceutical Quality of Conventional Dosage Forms Containing Paracetamol and Caffeine Available in the Turkish Drug Market

Abstract

The aim of this study was to evaluate the quality of conventional paracetamol-(PA) and caffeine-(CA) containing combined dosage forms in the Turkish drug market. For this purpose, weight variation, content uniformity, diameter and thickness, hardness, friability, disintegration, and dissolution tests were carried out. Content uniformity and dissolution tests were performed by a validated high-performance liquid chromatography (HPLC) method. Separations were carried on an ACE 5-C 18 , 5-µm LC column (250 × 4.6 mm) using isocratic elution with a methanol/water (40:60 v/v) mobile phase. The injection volume was 20 μL, and UV detection was performed at 270 nm. The weight variation results were in accordance with content uniformity results. All dosage forms fulfilled the USP requirement of not less than 75% of active ingredients of the labeled claim dissolved within 60 min. Also, all tablets met the rapidly dissolving criterion (more than 85% of the labeled amount of the drug substance dissolved within 30 min). The results of this study indicate that PA-and CA-containing conventional dosage forms available in the Turkish drug market pass all the established quality control tests successfully, and they can be used interchangeably.

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Türk İlaç Pazarında Mevcut Olan, Metoprlol Tartarat Uzatılmış Salımlı Tabletlerinin Salım Kinetiklerinin ve Farmasötik Kalitelerinin Değerlendirilmesi.

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