HPLC测定米氮平透皮软膏含量及其稳定性初步分析OA

To establish a high-performance liquid chromatography(HPLC)method for the quantitative determination of mirtazapine in transdermal ointments and to conduct a preliminary analysis of its stability,this study utilized an InertSustain C18 chromatographic column.The mobile phase consisted of methanol:tetrahydrofuran:acetonitrile:tetramethylammonium hydroxide buffer solution(12.5:7.5:15:65,v/v/v/v),with a detection wavelength of 290 nm,a flow rate of 1.5 mL/min,and a column temperature of 40℃.Stability testing of the ointment was performed under conditions of light exposure,high temperature,high humidity,and after packaging in aluminum pharmaceutical ointment tubes,including accelerated and long-term stability trials.The results showed that neither the blank solvent nor excipients interfered with the detection of mirtazapine.When using 50％acetonitrile as the solvent,the reference standard demonstrated good linearity between concentration(236.78-355.17 µg/mL)and peak area(R2=0.999 7).The average recovery rate of mirtazapine was 100.05％,with a relative standard deviation(RSD)of 0.61％.Both the test sample and the standard solution remained stable at room temperature for 24 hours.Under stability testing,high temperature(60℃)caused the mirtazapine content to decline from 100.40％ to 97.26％,whereas high humidity,light exposure,and both accelerated and long-term tests showed no significant effect on the mirtazapine content in the ointment.In conclusion,the established HPLC method exhibited strong specificity and high accuracy,making it suitable for quantifying mirtazapine in transdermal ointments.Additionally,aluminum pharmaceutical ointment tubes are appropriate packaging for the product,but high temperatures should be avoided during storage and transportation.