活性药物成分和片剂中 Empagliflozin 的分光光度法开发与验证

IF 0.8 4区 化学 Q4 SPECTROSCOPY Journal of Applied Spectroscopy Pub Date : 2024-05-11 DOI:10.1007/s10812-024-01734-8
Sagar Sahu, Ravindra Kumar Pandey, Shiv Shankar Shukla, Bina Gidwani
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引用次数: 0

摘要

Empagliflozin 是钠葡萄糖共转运体 SGLT-2 的抑制剂,主要存在于肾脏近端肾小管中。采用独特、安全、灵敏的紫外分光光度法对片剂形式的 Empagliflozin 进行了检测。在开发和验证安帕格列净检测方法的过程中,使用了甲醇作为溶剂。通过紫外分光光度计扫描确定溶液的最大吸光波长。在指定波长下,使用各种校准标准测量吸光度。计算了浓度与吸光度校准曲线的线性和范围。确定了分析方法的准确度、精确度、检测限、定量限和耐用性等指标。相关系数为 0.999,表明在 2-10 μg/mL 浓度范围内呈线性关系。甲醇中恩帕格列净的最大吸光度为 238.5 纳米。根据国际协调会议准则对回收率进行了估算,发现回收率为 93.25%。所开发的紫外方法精确度高,相对标准偏差小于 2%。使用紫外分光光度法评估片剂中的恩格列净既安全又有帮助。这项研究的独特之处在于采用了一种经济、省时、安全、简便且成功的方法来验证安格列净。
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Spectrophotometric Method Development and Validation of Empagliflozin in Active Pharmaceutical Ingredient and Tablet Dosage Form

Empagliflozin, an inhibitor of SGLT-2, a sodium glucose co-transporter is found mainly in the proximal tubules of the nephronic components of the kidney. The assay of empagliflozin in its tablet form has been created using a unique, secure, and sensitive UV-spectrophotometric approach. During the development and validation of the method for the assay of empagliflozin, methanol was employed as the solvent. The maximum absorbance wavelength of the solution was determined by scanning in a UV spectrophotometer. At the specified wavelength; absorbance was measured using a variety of calibration standards. The linearity and range of the calibration curve of concentration vs. absorbance were computed. The accuracy, precision, limit of detection, limit of quantitation, and ruggedness of the analytical approach were among the metrics that were determined. A correlation coefficient of 0.999 indicated linearity within the concentration range 2–10 μg/mL. The maximum absorbance of empagliflozin in methanol was determined to be 238.5 nm. Recovery was estimated as per International Conference on Harmonization guidelines and was found to be as per the acceptance limits: 93.25%. The developed UV method was found to be precise with relative standard deviation less than 2%. The assessment of empagliflozin in its tablet formulation using a UV-spectrophotometric technique was determined to be both safe and helpful. The uniqueness of this research is based on a cost-efficient, time-saving, safe, easy, and successful approach for validating empagliflozin.

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来源期刊
CiteScore
1.30
自引率
14.30%
发文量
145
审稿时长
2.5 months
期刊介绍: Journal of Applied Spectroscopy reports on many key applications of spectroscopy in chemistry, physics, metallurgy, and biology. An increasing number of papers focus on the theory of lasers, as well as the tremendous potential for the practical applications of lasers in numerous fields and industries.
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