反相高效液相色谱法快速分析拉米夫定和多替格拉韦的处方、稳定性研究

D. Mamata, Srinu Naik Sapavatu
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引用次数: 0

摘要

建立了同时分析拉米夫定和多替格拉韦的反相高效液相色谱方法,并将其应用于药物稳定性研究。用磷酸盐缓冲液(pH 5.0)和乙腈(60:40 v/v)在Std discovery C18 (150 × 4.6 mm, 5µ)柱上快速洗脱标题分析物。用PDA检测器在260 nm处进行检测。以1ml /min的恒定流速对溶液进行色谱。拉米夫定和多路地韦洗脱时间分别为2.37 min和2.97 min,洗脱时间较好。方法按照ICH指南进行验证。拉米夫定和多替重力韦的线性范围分别为18.75 ~ 112.5µg/mL和3.125 ~ 18.75µg/mL。精密度研究的% RSD值< 2表示方法的重复性。拉米夫定和多替重力韦的加样回收率分别为100.17%和100.36%,均在限定范围内。该方法可用于各种应激条件下药物的处方分析和稳定性研究。
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RP-HPLC method for swift analysis of Lamivudine and Dolutegravir in formulation, stability studies
New RP-HPLC method have been developed for simultaneous analysis of lamivudine and dolutegravir in pharmaceutical dosage forms and applied to stability studies of drugs. The title analytes were eluted rapidly with phosphate buffer (pH 5.0) and acetonitrile (60:40 v/v) on Std discovery C18 (150 x 4.6 mm, 5 µ) column. The detection was carried out using PDA detector at 260 nm. The solutions were chromatographed at a constant flow rate of 1 mL/min. Lamivudine and Dolutegravir were eluted at 2.37 min and 2.97 min respectively with good resolution. Method was validated as ICH guidelines. The linearity range of lamivudine and dolutegravir were found to be of 18.75 - 112.5 µg/mL and 3.125 - 18.75 µg/mL, respectively. The % RSD values (< 2) in precision studies indicates the reproducibility of method. The percentage recoveries were 100.17 % and 100.36 % respectively for lamivudine and dolutegravir, found to be within the limits. The proposed validated method was fruitfully applied for assay of formulation and stability studies of drugs under various stress conditions.
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