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首页> 外文期刊>American Journal of Analytical Chemistry >Validated HPTLC Method for Simultaneous Estimation of Isotretinoin and Erythromycin in Bulk Drug and Topical Gel Form
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Validated HPTLC Method for Simultaneous Estimation of Isotretinoin and Erythromycin in Bulk Drug and Topical Gel Form

机译：同时验证散装药物和局部凝胶形式中异维A酸和红霉素的有效HPTLC方法

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A simple, precise and accurate high performance thin layer chromatographic method has been developed for the simultaneous estimation of Isotretinoin and Erythromycin in pharmaceutical gel. The separation was carried out on Merck TLC aluminum sheets of silica gel 60 F254, (20 × 10 cm) with 250 μm thickness using toluene: DMSO: methanol (6.5:0.2:2.5, v/v/v) as a mobile phase. HPTLC separation of the two drugs followed by densitometric measurement of their spots at 340 nm for Isotretinoin before derivatization and 410 nm for Erythromycin after derivatization with 10% H2SO4 and heating at 100°C for 15 min. The drugs were satisfactorily resolved with RF values of 0.38 ± 0.02 and 0.55 ± 0.02 for Isotretinoin and Erythromycin, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (30-150 ng spot-1 for Isotretinoin and 1200-6000 ng spot-1 for Erythromycin), precision (intra-day RSD 0.62-0.79% and inter-day RSD 0.43-0.71 % for Isotretinoin and intra-day RSD 0.47-1.71 % and inter-day RSD 0.42-1.49 % for Erythromycin), accuracy (98.91 ± 0.92 % for Isotretinoin and 99.27 ± 0.72 % for Erythromycin), and specificity, in accordance with ICH guidelines.
机译：已经开发了一种简单，精确和准确的高性能薄层色谱方法，用于同时估算药物凝胶中的异维A酸和红霉素。使用甲苯：DMSO：甲醇（6.5：0.2：2.5，v / v / v）作为流动相，在250μm厚的硅胶60 F254（20×10cm）的Merck TLC铝片上进行分离。两种药物的HPTLC分离，然后光密度测定衍生化前的异维A酸在340 nm处，用10％H2SO4衍生并在100°C加热15分钟后对红霉素在410 nm处进行光密度测量。异维A酸和红霉素的RF值分别为0.38±0.02和0.55±0.02，可令人满意地拆分药物。该方法的准确性和可靠性通过评估线性（异维A酸为30-150 ng spot-1和红霉素为1200-6000 ng spot-1），精度（日内RSD为0.62-0.79％和日间RSD）进行评估异维A酸为0.43-0.71％，红霉素的日内RSD为0.47-1.71％和日间RSD为0.42-1.49％），准确性（异维A酸为98.91±0.92％，红霉素为99.27±0.72％）以及特异性与ICH指南。

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