Chauhan Bhupendrasinh, Rani Shubha, Guttikar Swati, Zope Anjali, Jadon Nimisha, Padh Harish
B.V. Patel Pharmaceutical Education and Research Development (PERD) Centre, Thaltej-Gandhinagar Highway, Thaltej, Ahmedabad 380 054, India.
J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Sep 5;823(2):69-74. doi: 10.1016/j.jchromb.2005.05.042.
Mianserin is a tetracyclic antidepressant drug and administered as racemate of R (-) and S (+) mianserin hydrochloride in a dose of 30-90 mg/day in divided doses. Liquid chromatography-mass spectroscopy (LC-MS) is a tool, which is widely used for determination of drug and their metabolites in biological fluids because of its high sensitivity and precision. Here we describe a liquid chromatography mass spectroscopy method for simultaneous determination of mianserin and its metabolite, N-desmethylmianserin, from human plasma using a liquid-liquid extraction with hexane:isoamylalcohol (98:2) and back extraction with 0.005 M formic acid solution. This method is specific and linear over the concentration range of 1.00-60.00 ng/ml for mianserin and 0.50-14.00 ng/ml for N-desmethylmianserin in human plasma. The lowest limits of quantification (LLQ) is 1.00 ng/ml for mianserin and 0.50 ng/ml for N-desmethylmianserin. Intraday and interday precision (%C.V.) is <10% for both mianserin and N-desmethylmianserin. The accuracy ranges from 94.44 to 112.33% for mianserin and 91.85-100.13% for N-desmethylmianserin. The stability studies showed that mianserin and N-desmethylmianserin in human plasma are stable during short-term period for sample preparation and analysis. The method was used to assay mianserin and its metabolite, N-desmethylmianserin, in human plasma samples obtained from subjects who had been given an oral tablet of 30 mg of mianserin.
米安色林是一种四环类抗抑郁药，以R（-）和S（+）盐酸米安色林的外消旋体形式给药，剂量为30 - 90毫克/天，分剂量服用。液相色谱 - 质谱联用（LC - MS）是一种工具，因其高灵敏度和高精度而被广泛用于测定生物流体中的药物及其代谢物。在此，我们描述了一种液相色谱 - 质谱方法，用于同时测定人血浆中的米安色林及其代谢物N - 去甲基米安色林，该方法采用正己烷：异戊醇（98:2）液 - 液萃取，并用0.005 M甲酸溶液进行反萃取。该方法在人血浆中米安色林浓度范围为1.00 - 60.00纳克/毫升、N - 去甲基米安色林浓度范围为0.50 - 14.00纳克/毫升时具有特异性且呈线性。米安色林的最低定量限（LLQ）为1.00纳克/毫升，N - 去甲基米安色林的最低定量限为0.50纳克/毫升。米安色林和N - 去甲基米安色林的日内和日间精密度（%变异系数）均<10%。米安色林的准确度范围为94.44%至112.33%，N - 去甲基米安色林的准确度范围为91.85%至100.13%。稳定性研究表明，人血浆中的米安色林和N - 去甲基米安色林在短期样品制备和分析过程中是稳定的。该方法用于测定从服用30毫克米安色林口服片剂的受试者获得的人血浆样品中的米安色林及其代谢物N - 去甲基米安色林。
