DEVELOPMENT AND VALIDATION OF A SIMPLE AND COST-EFFECTIVE UV SPECTROPHOTOMETRIC METHOD FOR QUANTIFYING LINEZOLID

Q2 Pharmacology, Toxicology and Pharmaceutics

International Journal of Applied Pharmaceutics Pub Date : 2024-05-07 DOI:10.22159/ijap.2024v16i3.50556

Iti Chauhan, Lubhan Singh

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引用次数: 0

Abstract

Objective: This study focuses on the development and validation of a sensitive, simple, accurate, precise and cost-effective Ultraviolet-Visible (UV) spectrophotometric method for the quantification of Linezolid, a widely used antibiotic in pharmaceutical formulations. Methods: The analysis utilized a solvent system comprising 80% water and 20% methanol (v/v). The absorbance of standard solutions was measured and a calibration curve was constructed. Various analytical performance parameters, including linearity, range, precision, accuracy, Limit of Detection (LOD), Limit of Quantification (LOQ) and ruggedness, were determined following the International Conference on Harmonization (ICH) Q2 (R1) guidelines. Results: The maximum absorption peak (λmax) of Linezolid was determined to be 251 nm in the selected medium. Beer-Lambert’s law was valid in the concentration range of 0.5–9 μg/ml, with a high correlation coefficient (R2) of 0.9955. The proposed method exhibited a recovery ranging from 99.08 to 100.37% with % Relative Standard Deviation (RSD) value consistently below 2%. Conclusion: The study findings confirm the accuracy, precision and reproducibility of the developed method. Additionally, it is characterized by its simplicity, affordability, and time efficiency. Thus, this method can be effectively employed for the quantification of Linezolid in lipid nanoparticles.

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开发并验证一种简单、经济的紫外分光光度法定量利奈唑胺

研究目的本研究的重点是开发和验证一种灵敏、简单、准确、精确且经济高效的紫外分光光度法，用于定量检测药物制剂中广泛使用的抗生素利奈唑胺：分析采用的溶剂系统为 80% 的水和 20% 的甲醇（v/v）。测量标准溶液的吸光度并构建校准曲线。根据国际协调会议（ICH）Q2 (R1)指南确定了各种分析性能参数，包括线性、范围、精密度、准确度、检测限（LOD）、定量限（LOQ）和耐用性：结果：在所选培养基中，利奈唑胺的最大吸收峰 (λmax) 被确定为 251 nm。比尔-朗伯定律在 0.5-9 μg/ml 浓度范围内有效，相关系数 (R2) 为 0.9955。该方法的回收率为 99.08% 至 100.37%，相对标准偏差（RSD）始终低于 2%：研究结果证实了所开发方法的准确性、精确性和可重复性。此外，该方法还具有简便、经济、省时的特点。因此，该方法可有效地用于脂质纳米颗粒中利奈唑胺的定量分析。

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来源期刊

International Journal of Applied Pharmaceutics Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

CiteScore

1.40

自引率

0.00%

发文量

219

期刊介绍： International Journal of Applied Pharmaceutics (Int J App Pharm) is a peer-reviewed, bimonthly (onward March 2017) open access journal devoted to the excellence and research in the pure pharmaceutics. This Journal publishes original research work that contributes significantly to further the scientific knowledge in conventional dosage forms, formulation development and characterization, controlled and novel drug delivery, biopharmaceutics, pharmacokinetics, molecular drug design, polymer-based drug delivery, nanotechnology, nanocarrier based drug delivery, novel routes and modes of delivery; responsive delivery systems, prodrug design, development and characterization of the targeted drug delivery systems, ligand carrier interactions etc. However, the other areas which are related to the pharmaceutics are also entertained includes physical pharmacy and API (active pharmaceutical ingredients) analysis. The Journal publishes original research work either as a Original Article or as a Short Communication. Review Articles on a current topic in the said fields are also considered for publication in the Journal.