盐酸甲氟喹片剂剂型中含量测定的高效液相色谱法的建立与验证
Development and validation of an HPLC method for mefloquine hydrochloride determination in tablet dosage form.
作者信息
Nogueira Fernando Henrique Andrade, Goulart Letícia de Paula Lana, César Isabela da Costa, de Campos Lígia Maria Moreira, Pianetti Gérson Antônio
机构信息
Universidade Federal de Minas Gerais, Departamento de Produtos Farmacêuticos, Faculdade de Farmácia, Av. Pres. Antônio Carlos 6627, Sala 4029 Bloco 2, 31270-901, Belo Horizonte, MG, Brazil.
出版信息
J AOAC Int. 2011 Jul-Aug;94(4):1089-93.
A simple HPLC method for determination of mefloquine hydrochloride in tablets was developed and validated. The separation was carried out on an Xterra RP18 (250 x 4.6 mm id, 5 pm particle size) analytical column. The mobile phase was 0.05 M monobasic potassium phosphate buffer (pH 3.5)-methanol (40 + 60, v/v). The flow rate and wavelength were set to 1 mL/min and 283 nm, respectively. The method was specific for mefloquine hydrochloride in the presence of hydrolytic, oxidative, and photolytic degradation products. It was also linear, precise, accurate, and robust, being suitable for routine QC analyses and stability studies. The developed HPLC method was compared to a previously described spectrophotometric method.
建立并验证了一种用于测定片剂中盐酸甲氟喹的简单高效液相色谱法。分离在Xterra RP18（250×4.6 mm内径，5μm粒径）分析柱上进行。流动相为0.05 M磷酸二氢钾缓冲液（pH 3.5）-甲醇（40 + 60，v/v）。流速和波长分别设定为1 mL/min和283 nm。该方法在水解、氧化和光解降解产物存在的情况下对盐酸甲氟喹具有特异性。它还具有线性、精密度高、准确度高和稳健性好的特点，适用于常规质量控制分析和稳定性研究。将所建立的高效液相色谱法与先前描述的分光光度法进行了比较。
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