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METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR THE SIMULTANEOUS ESTIMATION OF ESCITALOPRAM AND ETIZOLAM IN BULK AND PHARMACEUTICAL DOSAGE FORM

机译:RP-HPLC在散装和药物剂型中同时估计Escitalopram和Etizolam的方法开发和验证

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摘要

The developed RP-HPLC method allows rapid and precise determinations of escitalopram and etizolam in bulk and pharmaceutical dosage forms. The objective of the proposed method was to develop a simple and accurate method for the determination of escitalopram and etizolam by RP-HPLC method in pharmaceutical dosage forms & its stability indicative studies. A series of mobile phases were tried; among the various mobile phases , potassium dihydrogen phosphate buffer and dipotassium hydrogen phosphate 0.02 M, pH 3.0 : acetonitrile (20:80) is an ideal mobile phase, since it gave a good resolution and peak shapes with perfect optimization. The flow rate was optimized at less than 2 mL/min. The linearity and correlation coefficient of escitalopram and etizolam at 0-45ug/mL and 0-75ug/mL was found to be 0.998 & 0.998, respectively. The LOD was found to be 0.1 mg/mL and 0.3 mg/mL and LOQ was found to be 0.15 mg/mL and 0.45 mg/mL for escitalopram and etizolam, respectively, which represents that sensitivity of the method is high. The method was known to be accurate with the assay method. The % assay was found to be 100 % and 98%. The developed method showed a good accuracy and precision. The % RSD is for escitalopram and etizolam was found to be 1.50 and 1.22. This method shows good reproducibility of the results. Furthermore, this method was simple, sensitive, and accurate. Hence, the chromatographic method developed for escitalopram & eizolam can be effectively applied for routine analysis.
机译:开发的RP-HPLC方法允许在体积和药物剂型中快速和精确地确定Escitalopram和Etizolam。该方法的目的是通过RP-HPLC方法在药物剂型和稳定性指示性研究中制定简单且准确的方法,以通过RP-HPLC方法测定Escitalopram和Etizolam。尝试了一系列移动阶段;在各种流动相中,磷酸二氢钾缓冲液和磷酸二钾0.02μm,pH 3.0:乙腈(20:80)是一种理想的流动阶段,因为它具有完美优化的良好分辨率和峰形状。流速在小于2mL / min的情况下进行优化。 EssitalOpram和Etizolam的线性度和相关系数在0-45ug / ml和0-75ug / ml分别为0.998&0.998。发现LOD为0.1mg / ml,分别发现0.3mg / ml和LOQ,分别为0.15mg / ml和0.45mg / ml,分别用于ESSIZAM和Etizolam,这表示该方法的敏感性高。已知该方法用测定方法准确。发现%测定为100%和98%。开发方法显示出良好的精度和精度。 %RSD用于Escitalopram,Etizolam被发现为1.50和1.22。该方法显示出结果的良好再现性。此外,这种方法简单,敏感,准确。因此,可以有效地施加对ESCITALOPRAM和EIZOLAM开发的色谱法用于常规分析。

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