稳定性指示RP-UPLC同时测定硫代秋糖苷和乙酰氯芬酸联合剂型的方法的建立与验证。

P. Balan, N. Kannappan
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引用次数: 8

摘要

建立了稳定性指示RP-UPLC同时测定片剂中硫代秋葡萄糖苷(TCC)和乙酰氯芬酸(ACF)含量的方法。色谱分离采用Thermo Scientific UPLC仪器,Accela 1250泵,自动进样器配PDA检测器,色谱柱为Thermo Scientific hypersil gold c18, (50 × 2.1mm)粒径1.9µm, 5%醋酸铵缓冲液与甲醇的比例为40:60,pH调至5,正磷酸为流动相,流速为250µl/min,检测波长为276nm。TCC和ACF的运行时间分别约为0.697和1.125分钟。TCC和ACF分别在4.8µg/ml ~ 7.2µg/ml和63.8µg/ml ~ 96µg/ml浓度范围内呈线性。TCC的线性回归方程为y= 20620x-677.68 (r2 = 0.9996), ACF的线性回归方程为y= 50931x-319.3 (r2 = 0.9997)。TCC的检出限和定量限分别为0.076µg和0.23µg, ACF的检出限分别为0.27µg和0.71µg。TCC和ACF的检测率分别为99.50%和99.96%。通过强制降解实验确定了其稳定性指示能力。该方法按照ICH指南进行了令人满意的验证。DOI: http://dx.doi.org/10.3329/icpj.v3i7.19078国际现代医药杂志,2014年6月,3(7):296-300
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and validation of stability-indicating RP-UPLC method for simul-taneous estimation of thiocolchicoside and aceclofenac in combined dosage form.
A stability indicating RP-UPLC method was developed and validated for the simultaneous determination of Thiocolchicoside (TCC) and Aceclofenac (ACF) in tablet dosage form. The chromatographic separation was carried out by Thermo Scientific UPLC Instrument, Accela 1250 Pump, auto sampler with PDA detector, using column Thermo Scientific hypersil gold C 18 , (50 x 2.1mm) particle size 1.9µm using 5% ammonium acetate buffer and methanol in the ratio of 40:60, pH was adjusted to 5 with ortho phosphoric acid as mobile phase at a flow rate of 250 µl/min with the detection at 276nm. The run times of the TCC and ACF were about 0.697 and 1.125 minutes, respectively. The detector response is linear from 4.8 µg/ml to 7.2 µg/ml and 63.8 µg/ml to 96 µg/ml concentrations for TCC and ACF respectively. The linear regression equation was found to be y = 20620x-677.68 (r 2 = 0.9996) for TCC and y= 50931x-319.3 (r 2 = 0.9997) for ACF. The detection limit and quantification limit was 0.076µg and 0.23µg for TCC and 0.27µg and 0.71µg for ACF. The percentage of assay of TCC and ACF were about 99.50% and 99.96% respectively. The stability indicating capability was established by forced degradation experiments. The method was satisfactorily validated as per the ICH guidelines. DOI:  http://dx.doi.org/10.3329/icpj.v3i7.19078 International Current Pharmaceutical Journal, June 2014, 3(7): 296-300
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