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反相高效液相色谱法用于分析药物制剂中的来曲唑。

Reverse phase high performance liquid chromatographic method for the analysis of letrozole in pharmaceutical dosage forms.

作者信息

Laha T K, Patnaik R K, Sen S

机构信息

Cancer Chemotherapeutic Research Unit, College of Pharmaceutical Sciences, At/PO: Mohuda, Ganjam, Berhampur-760 002, India.

出版信息

Indian J Pharm Sci. 2008 May-Jun;70(3):401-3. doi: 10.4103/0250-474X.43019.

DOI:10.4103/0250-474X.43019
PMID:20046760
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2792508/
Abstract

A rapid and sensitive reverse phase high performance liquid chromatographic method is depicted for the qualitative and quantitative assay of letrozole in pharmaceutical dosage forms. Letrozole was chromatographed on a reverse phase C18 column with a mobile phase consisting of acetonitrile and phosphate buffer (pH 7.8) in the ratio of 70:30 v/v. The mobile phase was pumped at a flow rate of 1 ml/min. Acenaphthene was used as an internal standard and the eluents were monitored at 232 nm. The retention time of the drug was 3.385 min. With this method, linearity was observed in the range of 10-100 mug/ml. The LOD and LOQ were found to be 0.51 mug/ml and 1.52 mug/ml, respectively. The method was found to be applicable for analysis of drug in tablets. The results of the analysis were validated statistically.

摘要

描述了一种快速灵敏的反相高效液相色谱法,用于药物剂型中来曲唑的定性和定量测定。来曲唑在反相C18柱上进行色谱分析,流动相由乙腈和磷酸盐缓冲液(pH 7.8)按70:30 v/v的比例组成。流动相以1 ml/min的流速泵送。苊用作内标,洗脱液在232 nm处进行监测。药物的保留时间为3.385分钟。用该方法,在10-100μg/ml范围内观察到线性关系。检测限和定量限分别为0.51μg/ml和1.52μg/ml。该方法适用于片剂中药物的分析。分析结果经统计学验证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b46/2792508/4b6aa7fa2713/IJPhS-70-401-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b46/2792508/4b6aa7fa2713/IJPhS-70-401-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b46/2792508/4b6aa7fa2713/IJPhS-70-401-g001.jpg

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本文引用的文献

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Letrozole-, anastrozole-, and tamoxifen-responsive genes in MCF-7aro cells: a microarray approach.MCF-7aro细胞中对来曲唑、阿那曲唑和他莫昔芬敏感的基因:一种微阵列方法。
Mol Cancer Res. 2005 Apr;3(4):203-18. doi: 10.1158/1541-7786.MCR-04-0122.
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Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: results of a phase III study of the International Letrozole Breast Cancer Group.来曲唑对比他莫昔芬作为绝经后晚期乳腺癌女性一线治疗的疗效更佳:国际来曲唑乳腺癌研究组III期研究结果
J Clin Oncol. 2001 May 15;19(10):2596-606. doi: 10.1200/JCO.2001.19.10.2596.
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用于测定原料药和药物制剂中来曲唑的分光光度法。
J Adv Pharm Technol Res. 2010 Jul;1(3):348-53. doi: 10.4103/0110-5558.72425.
Letrozole. A review of its use in postmenopausal women with advanced breast cancer.
来曲唑。关于其在绝经后晚期乳腺癌女性中应用的综述。
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