Bioequivalence Study and Bioanalytical Method Development of Remogliflozin etabonate tablets in wistar rat plasma using RP-HPLC Method

Q3 Pharmacology, Toxicology and Pharmaceutics

Research Journal of Pharmacy and Technology Pub Date : 2024-02-20 DOI:10.52711/0974-360x.2024.00122

N. Tamilselvi, K. Kanagapriya

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Abstract

A new RP-HPLC method for the bioequivalence study of two RGE (Remogliflozin etabonate) formulations in wistar rat plasma has been developed using Rosuvastatin as internal standard and validated as per ICH guidelines. The plasma samples were extracted with methanol and chromatographic separation was achieved on phenomenex C18 (250 x 4.6mm, 5μ) analytical column with a mobile phase of methanol: 0.2% TEA (pH adjusted to 3 with orthophosphoric acid) in the ratio of 78:22% v/v and detection at 227nm. Calibration curve was linear in the range of 100-600ng/ml and the r2 value was found to be 0.9906. The extraction efficiency of RGE from rat plasma at the concentration of 50, 100 and 150% was found to be 99.6%, 99.9% and 98.05%. The Intra-day precision and interday precision was found to be 0.14 - 0.777% and 0.0070% - 0.0572% respectively. The maximum concentration (Cmax) obtained for two brands ( selected brand 1 & 2) formulation are 57.04 and 51.99 ng/ml respectively. The half life (t1/2) of two brands are calculated as 1 h. Area under the curve AUC 0- t of brand 1 and brand 2 is calculated as 343.235 and 310.1775ng h/ml and AUC 0-∞ is calculated to be 465.3665 and 501.4235ng h/ml respectively. The present study shows no significant difference in pharmacokinetic parameters between two products so the two formulations are considered to be bioequivalent.

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采用 RP-HPLC 方法对瑞莫利嗪依他朋酯片剂在雾大鼠血浆中的生物等效性进行研究并开发生物分析方法

以瑞舒伐他汀为内标物，开发了一种新的 RP-HPLC 方法，用于研究两种 RGE（雷莫格列嗪依他朋酸盐）制剂在雾鼠血浆中的生物等效性，并按照 ICH 指南进行了验证。血浆样品用甲醇提取，在 phenomenex C18（250 x 4.6mm，5μ）分析柱上进行色谱分离，流动相为甲醇：0.2%三乙醇胺（用正磷酸调节 pH 值至 3），流速为 78:22% v/v，检测波长为 227nm。校准曲线在 100-600ng/ml 范围内呈线性关系，r2 值为 0.9906。在浓度为 50%、100% 和 150% 时，大鼠血浆中 RGE 的提取率分别为 99.6%、99.9% 和 98.05%。日内精密度和日间精密度分别为 0.14 - 0.777% 和 0.0070% - 0.0572%。两个品牌（选定品牌 1 和 2）制剂的最大浓度（Cmax）分别为 57.04 和 51.99 纳克/毫升。品牌 1 和品牌 2 的曲线下面积 AUC 0- t 分别为 343.235 和 310.1775ng h/ml，AUC 0-∞ 分别为 465.3665 和 501.4235ng h/ml。本研究表明，两种产品的药代动力学参数无明显差异，因此认为两种制剂具有生物等效性。

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来源期刊

Research Journal of Pharmacy and Technology Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

CiteScore

1.40

自引率

0.00%

发文量

期刊介绍： Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal, devoted to pharmaceutical sciences. The aim of RJPT is to increase the impact of pharmaceutical research both in academia and industry, with strong emphasis on quality and originality. RJPT publishes Original Research Articles, Short Communications, Review Articles in all areas of pharmaceutical sciences from the discovery of a drug up to clinical evaluation. Topics covered are: Pharmaceutics and Pharmacokinetics; Pharmaceutical chemistry including medicinal and analytical chemistry; Pharmacognosy including herbal products standardization and Phytochemistry; Pharmacology: Allied sciences including drug regulatory affairs, Pharmaceutical Marketing, Pharmaceutical Microbiology, Pharmaceutical biochemistry, Pharmaceutical Education and Hospital Pharmacy.