DETERMINATION OF PARACETAMOL LEVELS IN TABLETS AND ORAL SOLUTIONS BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC)

Abstract

According to RI Law no. 36 of 2009, determining the level of efficacious substances from a drug preparation is one of the requirements that must be carried out to ensure the quality of the drug preparation. Drug preparations of good quality will provide the expected effect and one of the parameters is the level of the active substance of the drug must meet the level requirements listed in the Indonesian Pharmacopeia or other standard books. The purpose of this study was to determine the levels of Paracetamol in tablet preparations and oral solution by high-performance liquid chromatography. The determination of the concentration was carried out by the HPLC method using a 2.5 mm x 25 cm VP-ODS shim pack column with water-methanol as a mobile phase (3:1), a flow rate of approximately 1.5 ml/minute, and the detection was carried out at a wavelength of 243 nm. The advantage of the HPLC method is the separation system with high speed and efficiency because it is supported by advances in column technology, high-pressure pump systems, and highly sensitive and diverse detectors so that they are able to analyze various samples qualitatively and quantitatively, back in single or mixed components. The results showed that all the specified samples met the content requirements according to the Indonesian Pharmacopeia IV edition 1995, namely not less than 90.0% and not more than 110.0% of the amount stated on the label. The results of the Validation test method carried out obtained a recovery percent of 99.96% with an RSD (Relative Standard Deviation) of 1.81% so that it can be concluded that this method has good sensitivity and accuracy, with a LOD (limit of detection) 0.76 g/ml and LOQ (limit of quantitation) 2.56 g/ml.