使用 C18 分析柱(安捷伦)的高效液相色谱法(HPLC),以 "质量源于设计 "的方法估算盐酸环苯扎林散剂及其片剂的含量

Deepak D. Pokharkar, Raghavdeep Sharma, Shreelekha N. Desai, Lekha Dhake
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引用次数: 0

摘要

盐酸环苯扎林用于治疗急性、不适性肌肉骨骼疾病引起的肌肉痉挛。这项工作的主要目的是开发准确、快速和精确的盐酸环苯扎林 HPLC 方法。所采用的方法是中央复合设计法,以获得准确的程序数据。各种参数用于验证和开发方法。用于分析盐酸环苯扎林的优化模型的面积为 8.3239。优化采用 C18 分析柱(安捷伦),流动相为甲醇:0.01 % 正磷酸(61:39 v/v),流速为 0.9 ml/min,检测波长为 224 nm。利用相关系数(r2=0.999)确定了盐酸环苯扎林在 5-25 微克/毫升范围内的线性关系。准确度值介于 99.86% 和 100.71% 之间。流速的稳健性小于 0.06,波长的 RSD 为 0.09%,日内和日间精密度分别低于 0.28% 和 0.29%。上述方法是分析盐酸环苯扎林最有效的方法。对盐酸环苯扎林 HPLC 技术的开发和验证进行了评估。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Validated HPLC Method using C18 Analytical Column (Agilent) for the Estimation of Cyclobenzaprine Hydrochloride by Quality by Design Approach in Bulk and Its Tablet Dosage Form
Cyclobenzaprine hydrochloride is used to treat muscle spasms brought on by acute, uncomfortable musculoskeletal diseases. The primary objective of this work is to develop accurate, quick and precise HPLC method for Cyclobenzaprine hydrochloride. The method used is a Central Composite Design to get exact data for the procedure. Various parameters were used to validate and to develop method. The optimized model for the analysis of  Cyclobenzaprine Hydrochloride was found to have an area 8.3239. This optimization was done on the  C18 analytical column(Agilent) with mobile phase as methanol: 0.01 % Orthophosphoric acid (61:39 v/v) and a flow rate maintain was 0.9 ml/min with a detection wavelength of 224 nm. With the use of a correlation coefficient (r2=0.999), the linearity of Cyclobenzaprine hydrochloride in the 5–25 ug/ml range was determined. The accuracy values were discovered to fall between 99.86 and 100.71%. While the robustness was shown to be less than 0.06 for flow rate and for wavelength was 0.09 % RSD, also the intraday and interday precision were determined to be under 0.28 and 0.29 % RSD. The most effective approach for analysing Cyclobenzaprine hydrochloride is the one that has been presented. The development and validation of the HPLC technique for Cyclobenzaprine hydrochloride were assessed.
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