稳定性指示UHPLC法测定地文拉法辛:降解动力学的应用

H. Akter, Md. Mahbubul Alam, Md Rezoan Rabbi, A. S. Shamsur Rouf
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摘要

采用反相超高效液相色谱(RP-UHPLC)系统研究地文拉法辛的降解行为及其理化稳定性。色谱柱为Eclipse XDB-C8 (150 × 4.6 mm, 5μm)。通过光电二极管阵列+ (PDA+)检测器在210 nm处采用等温法,流速为1.5 ml/min对洗脱液进行监测。流动相组成为0.1%三氟乙酸(TFA)与水和甲醇的混合物:30:70 v/v。按照国际统一会议(ICH)规定的应激条件(Q1A(R2)和Q1B),采用水解(酸性、碱性和中性)、氧化和光解方法对地文拉法辛原药进行强制降解研究。该原料药在酸性(0.5 N盐酸,在70℃下2小时降解18.65%)、碱性(1.0 N氢氧化钠,在70℃下12小时降解11.01%)和氧化(3%过氧化氢,在50℃下2小时降解17.05%)条件下非常不稳定,但对干热有很强的抗性(从环境温度到更高温度,80℃,10天内最大降解0.27%)。湿热(在80°C和75%相对湿度下,2小时内最大降解率为0.25%)以及光解降解(在315 - 400 nm的紫外线下,10天内最大降解率为0.23%)。在酸性、碱性和过氧化物三种降解方法中均遵循准一级动力学,为计算原料药地文拉法辛在ICH条件下的半衰期奠定了基础。对结果进行统计分析,并将% RSD值与推荐指南进行比较。达卡大学药学院。科学通报20(2):167-176,2021 (12)
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stability-Indicating UHPLC Method for the Determination of Desvenlafaxine: Application to Degradation Kinetics
This study was aimed to investigate the degradation behavior and physicochemical stability of desvenlafaxine using reversed-phase ultra-high-performance liquid chromatography (RP-UHPLC) system. The chromatogram was developed on Eclipse XDB-C8 column (150 x 4.6 mm, 5μm). The eluents were monitored through a photo diode array plus (PDA+) detector at 210 nm using an isocratic method with a flow rate of 1.5 ml/min. Mobile phase composition was 30:70 v/v mixture of 0.1 % trifluoroacetic acid (TFA) in water and methanol. Forced degradation studies were performed on drug substance of desvenlafaxine as per International Conference on Harmonization (ICH) prescribed stressed conditions (Q1A(R2) and Q1B) using hydrolytic (acidic, basic, and neutral), oxidative and photolytic methods. The drug substance was found highly labile to acidic (0.5 N hydrochloric acid, 18.65 % degradation in 2 hours at 70°C), basic (1.0 N sodium hydroxide, 11.01 % degradation in 12 hours at 70°C) and oxidative (3 % hydrogen peroxide, 17.05 % degradation in 2 hours at 50°C) stressed conditions, but a great resistance was observed towards dry heat (maximum degradation 0.27 % in 10 days from ambient to higher temperature, 80°C), moist heat (maximum degradation 0.25 % in 2 hours at 80°C and 75 % relative humidity) as well as in photolytic degradation (maximum degradation 0.23 % in 10 days at UV light of 315 - 400 nm). A pseudo-first order kinetic was followed in acidic, basic and peroxide degradation methods which paved a way to calculate the half-life of the drug substance desvenlafaxine under ICH mentioned stressed conditions. The results were also statistically analyzed and the % RSD values were compared with recommended guidelines. Dhaka Univ. J. Pharm. Sci. 20(2): 167-176, 2021 (December)
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