瑞格列奈处方中反相高效液相色谱法和紫外法的建立、验证和比较

Q4 Pharmacology, Toxicology and Pharmaceutics

INDIAN DRUGS Pub Date : 2023-09-28 DOI:10.53879/id.60.09.13574

Meghna P. Patel, Kushani N. Desai, Monika Sangani

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引用次数: 0

摘要

本研究建立了瑞格列奈片剂的紫外分光光度和反相高效液相色谱分析方法。紫外法在10 ~ 30 μg mL-1范围内线性良好，相对系数为0.9999。HpLC法在10 ~ 30 μ mL-1范围内线性良好，相关系数为0.9985。对每种方法进行特异性、重复性、准确度、精密度、线性、鲁棒性、检出限和定量限等不同验证参数的验证。结果是按照ICH指南获得的。通过单因素方差分析(ANOVA)检验，将所建立的紫外法和高效液相色谱法与现有的几种方法进行比较，发现差异有统计学意义

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DEVELOPMENT, VALIDATION AND COMPARISON OF RP-HPLC AND UV METHODS USING STATISTICAL ANALYSIS ONE WAY ANOVA TEST FOR REPAGLINIDE IN FORMULATION

In the present study, analytical UV and Rp-HpLC methods for repaglinide were developed for tablet formulation. UV method shows linearity in the range of 10-30 μg mL-1 with a relative coefficient of 0.9999. Linearity is shown in HpLC method in the range of 10- 30 μg mL-1 with a relative coefficient of 0.9985. each method was validated for different validation parameters like specificity, repeatability, accuracy, precision, linearity, robustness, limit of detection and limit of quantification. the results were obtained as per ICH guidelines. The developed UV and HpLC methods were compared with some available methods by statistical analysis one way ANOVA (Analysis of Variance) test, and it was found to be statistically significant

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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