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Novel approaches for determination of antiretroviral reverse transcriptase inhibitor agent in commercial dosage forms by using spectrofluorimetric, first derivative spectrophotometric, and HPLC methods
Future Journal of Pharmaceutical Sciences ( IF 3.4 ) Pub Date : 2020-09-04 , DOI: 10.1186/s43094-020-00070-w
Gizem Tiris , Emine Çiloğlu , Nevin Erk

Rapid, simple, and sensitive spectrofluorimetric, first derivative spectrophotometric, and high-performance liquid chromatographic (HPLC) methods have been developed and validated for determination of tenofovir in pharmaceutical preparations. Spectrofluorimetric method is based on measuring the native fluorescence intensity of tenofovir at 375.0 nm after excitation at 275.0 nm. Calibration graphics were plotted and were found linear over 4.72–15.75 μg/mL concentration range (r2 = 0.9994). The second method developed was the first derivative spectrophotometric method for the analysis of tenofovir performed by measuring the amplitude at 251.7 and 272.6 nm. Linearity was observed in the concentration range 10.0–28.0 μg/mL (r2 = 0.9998). On the other hand, HPLC with a diode array detector (DAD). Ritonavir was used as internal standard (IS). HPLC analysis was carried out on a C18 column (Wakosil-II 5 C18 AR, 4.6 × 250 mm) using a mobile phase consisting of acetonitrile: 0.5% formic acid (99.5:0.5; v/v) at a flow rate of 1.0 mL/min. Injection volume was 5.0 μL. DAD signals at 260.0 nm were used. HPLC method was found to be linear over the concentration range of 10.0–100.0 μg/mL (r2 = 0.9990). Intra- and inter-day analysis and recovery studies were carried out to investigate precision and accuracy of the proposed spectrofluorimetric, first derivative spectrophotometry and HPLC methods. We successfully applied the developed methods for determination of tenofovir in tablet formulation. Finally, the proposed methods were compared statistically.

中文翻译:

分光荧光法,一阶导数分光光度法和HPLC法测定商业剂型中抗逆转录病毒逆转录酶抑制剂的新方法

快速,简便,灵敏的分光荧光法,一阶导数分光光度法和高效液相色谱(HPLC)方法已经开发出来,并经过验证,可用于测定药物制剂中的替诺福韦。荧光光谱法是基于在275.0 nm激发后测量替诺福韦在375.0 nm的天然荧光强度。绘制标定图,发现在4.72–15.75μg/ mL浓度范围内呈线性(r2 = 0.9994)。研发出的第二种方法是通过测量251.7和272.6 nm处的振幅来进行替诺福韦分析的一阶导数分光光度法。在10.0–28.0μg/ mL的浓度范围内观察到线性(r2 = 0.9998)。另一方面,HPLC具有二极管阵列检测器(DAD)。利托那韦用作内标(IS)。HPLC分析在C18色谱柱(Wakosil-II 5 C18 AR,4.6×250 mm)上进行,使用的流动相为乙腈:0.5%甲酸(99.5:0.5; v / v),流速为1.0 mL /分钟。进样量为5.0μL。使用260.0 nm的DAD信号。发现HPLC方法在10.0–100.0μg/ mL的浓度范围内是线性的(r2 = 0.9990)。进行日内和日间分析与回收研究,以研究拟议的荧光光谱法,一阶导数分光光度法和HPLC方法的精密度和准确性。我们成功地应用了开发的方法测定片剂中替诺福韦的含量。最后,对提出的方法进行了统计比较。v / v),流速为1.0 mL / min。进样量为5.0μL。使用260.0 nm的DAD信号。发现HPLC方法在10.0–100.0μg/ mL的浓度范围内是线性的(r2 = 0.9990)。进行日内和日间分析与回收研究,以研究拟议的荧光光谱法,一阶导数分光光度法和HPLC方法的精密度和准确性。我们成功地应用了开发的方法测定片剂中替诺福韦的含量。最后,对提出的方法进行了统计比较。v / v),流速为1.0 mL / min。进样量为5.0μL。使用260.0 nm的DAD信号。发现HPLC方法在10.0–100.0μg/ mL的浓度范围内是线性的(r2 = 0.9990)。进行日内和日间分析与回收研究,以研究拟议的荧光光谱法,一阶导数分光光度法和HPLC方法的精密度和准确性。我们成功地应用了开发的方法测定片剂中替诺福韦的含量。最后,对提出的方法进行了统计比较。进行日内和日间分析与回收研究,以研究拟议的荧光光谱法,一阶导数分光光度法和HPLC方法的准确性和准确性。我们成功地应用了开发的方法测定片剂中替诺福韦的含量。最后,对提出的方法进行了统计比较。进行日内和日间分析与回收研究,以研究拟议的荧光光谱法,一阶导数分光光度法和HPLC方法的精密度和准确性。我们成功地应用了开发的方法测定片剂中替诺福韦的含量。最后,对提出的方法进行了统计比较。
更新日期:2020-09-04
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