化学计量辅助紫外分光光度法定量测定恩曲他滨和富马酸替诺福韦二氧吡酯

Q4 Pharmacology, Toxicology and Pharmaceutics

INDIAN DRUGS Pub Date : 2023-09-28 DOI:10.53879/id.60.09.13152

Santosh V. Gandhi, Smruti C. Shinde

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引用次数: 0

摘要

本研究的目的是利用主成分回归(pCR)和偏最小二乘(pLS)多变量校准方法验证紫外分光光度法同时测定片剂型恩曲他滨和富马酸替诺福韦二氧吡酯的能力。采用双光束紫外可见分光光度计(Jasco V-730)，石英池为1 cm，数据间隔为1 nm，扫描速度为400 nm min -1。选择的最佳波长范围为225 ~ 275 nm。得到的数据用Unscrambler X(10.5)(64位)软件处理。所建立的模型在富马酸替诺福韦二氧吡酯6 ~ 36 μ mL-1和恩曲他滨4 ~ 24 μ mL-1的浓度范围内均有较好的结果，相关系数大于0.995，% RSD小于2%。准确度研究表明，回收率在一定范围内。方法按照ICH Q2(R1)指南进行验证。

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CHEMOMETRIC ASSISTED UV SPECTROPHOTOMETRIC METHOD FOR QUANTIFICATION OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

The aim of this study was to verify the ability of the UV spectrophotometric method for the simultaneous determination of emtricitabine and tenofovir disoproxil fumarate in tablet dosage form using the principal Component Regression (pCR) and partial Least Squares (pLS) multivariate calibration methods. Double beam UV-Vis spectrophotometer (Jasco V-730) with 1 cm quartz cell with 1 nm data interval and scanning speed of 400 nm min -1 was used in the study. the optimized wavelength range selected was 225-275 nm. the data obtained was processed using Unscrambler X (10.5) (64bit) software. The developed models showed good results over the concentration range of 6-36 μg mL -1 for tenofovir disoproxil fumarate and 4-24 μg mL-1 for emtricitabine with co-relation coefficient greater than 0.995 and % RSD less than 2%. the accuracy studies show % recovery within limits. The method was validated as per ICH Q2(R1) guideline.

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来源期刊

INDIAN DRUGS Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science

CiteScore

0.30

自引率

0.00%

发文量