建立和验证紫外分光光度法测量散装和配制样品中的栓皮素含量

Q4 Pharmacology, Toxicology and Pharmaceutics

INDIAN DRUGS Pub Date : 2024-02-28 DOI:10.53879/id.61.02.14489

Kritika R. Saboo, Rohit R. Ghadge, Dhanashree P. Sanap, Sneha A. Agrawal

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引用次数: 0

摘要

根据 ICH 准则 Q2 (R1)，开发了一种紫外分光光度法，用于估算从瑞木果中分离出的栓皮苷。该方法简单、快速、准确且经济实惠。栓皮苷的波长为 294.3 nm，在 2-12 μg mL-1 浓度范围内呈线性关系，相关系数为 0.997。将该方法应用于药物制剂中，发现药物的估计值为 97.99%，与标签说明相符。该方法的准确度在 80% 至 120% 之间的三个不同水平上进行了测定，回收率为 98.54% 至 99.98%。较低的 RSD%值表明该方法准确且可重复。精确度参数包括日间变化、日内变化和重复性。RSD % 值低于 2 表明所开发的方法是精确的。在两名分析师的协助下，对所建议方法的耐用性进行了研究。

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ESTABLISHMENT AND AUTHENTICATION OF A UV SPECTROPHOTOMETRIC APPROACH FOR MEASURING EMBELIN CONTENT IN BULK AND FORMULATED SAMPLE

A UV-spectrophotometric method for the estimation of embelin isolated from Embelia ribes berries as per ICH guidelines Q2 (R1) was developed. It is simple, quick, accurate, and affordable. The wavelength of embelin was found to be 294.3 nm; and was linear in the concentration range 2-12 μg mL-1 with 0.997 correlation coefficient. The method was applied to pharmaceutical formulation and the drug estimated was found to be 97.99 % and was in good agreement with the label claim. The accuracy of the method was performed at three different levels, between 80 to 120 %; with % recovery obtained 98.54 - 99.98 %. The low values of % RSD indicate that the method is accurate and reproducible. Interday, intraday variations, and repeatability were studied as precision parameters. A lower % RSD value than 2 indicates the developed method is precise. Ruggedness of the proposed method was studied with the aid of two analysts.

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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