反相高效液相色谱法同时测定原料药和制剂中米诺地尔和非那雄胺的含量

P. Jay, Jinal N. Tandel, Usmagani Chhalotiya, Kirtan Patel
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引用次数: 1

摘要

采用高效液相色谱法对米诺地尔和非那雄胺进行定量分析,结果可靠、精确、准确。该方法以Phenomenex C 18 (250 mm × 4.6 mm, 5 μm)色谱柱为固定相,甲醇:水(85:15 v/v)为流动相。以1 mL / min -1的流速进行等压洗脱程序。洗脱物在223 nm处有明显的吸光度。根据ICH指南对RP-LC方法进行验证。米诺地尔和非那雄胺的保留时间分别为3.15 min和4.36 min。该方法在米诺地尔6 ~ 54µg mL -1和非那雄胺0.2 ~ 1.8µg mL -1范围内呈线性。米诺地尔的回收率为99.88 ~ 100.85%,非那雄胺的回收率为99.99 ~ 100.33%。所建立的反相液相色谱法具有定性和定量同时测定米诺地尔和非那雄胺原料药和制剂剂型的潜力。
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SIMULTANEOUS QUANTIFICATION OF MINOXIDIL AND FINASTERIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD
A strategic specific and sensitive quantitative analysis of Minoxidil and Finasteride has been developed by using HPLC with reliable, precise, and accurate result in bulk and marketed formulation. In this method Phenomenex C 18 (250 mm × 4.6 mm, 5 μm) column was used as stationary phase and a composition of Methanol: Water (85:15 v/v) was used as mobile phase. An isocratic elution programming has been done at a flow rate of 1 mL min -1 . The eluted analytes show appreciable absorbance at 223 nm. The proposed RP-LC method was validated according to ICH guidelines. The retention time of Minoxidil and Finasteride was found to be 3.15 min and 4.36 min respectively. The method was found to be linear over a range of 6 – 54 µg mL -1 for Minoxidil and 0.2-1.8 µg mL -1 for Finasteride. The percentage recovery was found to be 99.88-100.85 % for Minoxidil and 99.99-100.33 % for Finasteride. The proposed reverse phase LC method has potential qualitative as well as quantitative applications for simultaneous estimation of Minoxidil and Finasteride in bulk and pharmaceutical dosage form.
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来源期刊
European Chemical Bulletin
European Chemical Bulletin Chemistry-Chemistry (all)
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