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首页> 外文期刊>International Journal of Pharmacy and Pharmaceutical Sciences >RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF CLINDAMYCIN PHOSPHATE AND CLOTRIMAZOLE IN PHARMACEUTICAL DOSAGE FORMS
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RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF CLINDAMYCIN PHOSPHATE AND CLOTRIMAZOLE IN PHARMACEUTICAL DOSAGE FORMS

机译：RP-HPLC法同时开发测定药品中克林霉素磷酸酯和克霉唑的方法及验证

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Objective : The aim of this work was to develop and validate a simple Reverse Phase-High Performance Liquid Chromatography method for the simultaneous estimation of Clindamycin and Clotrimazole in pharmaceutical dosage forms. Methods : The mobile phase consists of phosphate buffer and Acetonitrile in the ratio of (48:52) with gradient programming, Hypersil BDS (250×4.6 mm,5μ) column used as stationary phase with a flow rate of 1 ml/min, injection volume 10 μl and the run time was 10 min. Detection wavelength was at 220 nm by using Photo Diode Array detector. Results : The retention times of Clindamycin and Clotrimazole were found to be 2.2 min and 5.7 min respectively. The method was validated according to ICH guidelines. Validation parameters like accuracy, precision, linearity, range, limit of detection, limit of quantification and robustness all were within the limits. The linearity responses of Clindamycin and Clotrimazole were found to be in the concentration ranges of 25-150 μg/ml and 50-300 μg/ml. The percentage recovery for both drugs was found in the range of 99-100%. The LOD & LOQ values for were found to be 1.29μg/ml and 3.93μg/ml and Clotrimazole were found to be 1.31μg/ml and 3.96 μg/ml, respectively. Conclusion : The results obtained are accurate and within the limits. Hence this method can be applicable for the estimation of Clindamycin and Clotrimazole in pharmaceutical dosage forms. Keywords : Clindamycin and Clotrimazole, RP-HPLC, Validation.
机译：目的：这项工作的目的是开发和验证一种简单的反相高效液相色谱方法，用于同时估算药物剂型中的克林霉素和克霉唑。方法：流动相由磷酸盐缓冲液和乙腈按比例（48:52）组成，采用梯度程序设计，Hypersil BDS（250×4.6 mm，5μ）色谱柱用作固定相，流速为1 ml / min，进样体积为10μl，运行时间为10分钟。通过使用光电二极管阵列检测器，检测波长为220nm。结果：克林霉素和克霉唑的保留时间分别为2.2分钟和5.7分钟。该方法已根据ICH指南进行了验证。验证参数（如准确性，精度，线性，范围，检测极限，定量极限和鲁棒性）均在极限范围内。发现克林霉素和克霉唑的线性响应在25-150μg/ ml和50-300μg/ ml的浓度范围内。两种药物的回收率百分比均在99-100％之间。的LOD和LOQ值分别为1.29μg/ ml和3.93μg/ ml，克霉唑的分别为1.31μg/ ml和3.96μg/ ml。结论：得到的结果是准确的并且在极限范围内。因此，该方法可用于药物剂型中克林霉素和克霉唑的估计。关键词：克林霉素和克霉唑，RP-HPLC，验证。

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