一种稳定性指示的高效液相色谱法测定原料药盐酸美甲嗪的方法

M. Ubale, M. Shioorkar, V. Choudhari
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引用次数: 0

摘要

建立了等容反相稳定高效液相色谱(HPLC)测定原料药中盐酸美甲嗪的方法。采用水Nova Pack C18 (250 × 4.6) mm, 5?流动相中含有1.0 gm磷酸二氢钠和1.0 gm 1-辛烷磺酸盐,于1000ml水中过滤混合。制备缓冲液、甲醇和乙腈的均匀混合物。检测波长为264 nm。对该方法进行了线性度、准确度(回收率)、精密度、系统适用性、选择性、鲁棒性等方面的验证,证明了该方法的稳定性。
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A validated stability-indicating HPLC assay method for Meclizine HCl in bulk drug
An isocratic reversed phase stability-indicating high-performance liquid chromatographic (HPLC) assay method was developed and validated for quantitative determination of Meclizine HCl in bulk drugs. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, using a Water Nova Pack C18 (250 x 4.6) mm, 5? column and the mobile phase containing 1.0 gm Sodium dihydrogen phosphate and 1.0 gm 1-octaneSulfonic acid salt in 1000ml water filter and mixed. Prepare a homogenous mixture of buffer, methanol and acetonitile. The detection was carried out at wavelength 264 nm. The developed method was validated with respect to linearity, accuracy (recovery), precision, system suitability, selectivity, robustness prove the stability indicating ability of the method.
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