Parasetamolün Parenteral Çözeltide Stabilite Göstergeli Miktar Tayini İçin Yüksek Performanslı Sıvı Kromatografisi Yöntemi Geliştirilmesi ve Validasyonu

Abstract

The analytical validation of the parenteral solution in the semi-permeable primary bag and the non-permeable primary vial packaging containing the active ingredient Paracetamol was completed by developing a stability indicating HPLC method and evaluating the validation parameters. Analysis of paracetamol in liquid dosage, based on the principle of reversed phase chromatography, 12.5 mM potassium dihydrogen phosphate and 10.33 mM dipotassium hydrogen phosphate were weighed and the mobile phase formed by mixing the solution prepared with 1000 ml of distilled water (pH:6.9) and methanol (95:5, v/v), C18 4.6 x 50 mm, 2.7 µm column, 30 ºC column temperature, 15 ºC autosampler temperature, 1.0 ml/min flow rate, 254 nm wavelength and 10 µl injection volume. Under these conditions, the retention time is 4 min and the total analysis time is 7 min. The method was validated according to the guidelines of the International Conference on Harmonization (ICH), and it was determined that the method, which was carried out as a result of forced degradation studies (oxidation, light, acid, base and temperature) carried out for the selectivity study, has high selectivity for paracetamol. The method was found to be linear in the concentration range of 0.625-5,000 µg/mL. Recovery studies were carried out in the same concentration range and at every point where linearity was studied, and it was found in the range of 100.01% and 101.91%. As a result of stability studies, it was determined that paracetamol standard solutions and sample solutions were stable at room temperature, 4 ºC and 15 ºC for 30 days. In intraday and interday accuracy and precision studies, RSD was less than 0.75% and RE was less than 0.02%, and the method was found to be suitable for routine analyses. According to the evaluation of the validation parameters, the method developed in this study is selective, precise, accurate, sensitive and reproducible.