建立高效液相色谱指纹图谱法测定黄花草ÃⅱÂÂDashmulÃⅱÂÂ和三氯甲烷提取物中盐酸含量

Attarde Dl, Pal Sc, Bhambar Rs
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引用次数: 0

摘要

HPTLC技术是根据ICH指南开发的一种有效的方法,用于估计三联叶三氯甲烷提取物(PI-AK)和选定的上市配方“Dashmul arishta”、“Dashmul kadha”中3 × 3批次的Premnine HCl。从文献中分离到盐酸脯氨酸(pr9 HCl, Pr-s),首次作为标准生物活性标记物进行定量分析。建立了Pr-S的流动相甲苯:丙酮:二乙胺(7:2:1),密度扫描λ max 283 nm处的Rf为0.59,重点进行PI-AK的特异性、指纹图谱和估计研究,并依次选择处方。在8 ~ 16 μg/波段的线性范围内,回归系数为0.9983,检出限为0.742 μg/波段,检出限为2.225。在提取物和配方上进行的%回收率的准确性,进一步进行了精度研究,应用单向方差分析来寻找F值,发现在限制范围内,因此没有显著差异。高效液相色谱法线性好、回收率高、精密度高,是一种有效的Pr-S分析方法,可作为原料和制剂的质量控制参数,符合WHO、FDA和药典的要求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Premnine HCl Estimation in Selected Formulations of âÂÂDashmulâ and inChloroform Extract of Premna integrifolia L. by a Selective, Validated andDeveloped HPTLC Fingerprint Method
HPTLC technique developed as validated method for estimation of Premnine HCl in P. integrifolia chloroform extract (PI-AK) and in selected marketed formulations ‘Dashmul arishta’,‘Dashmul kadha’ in 3 × 3 batches as per ICH guidelines. Premnine HCl (Pr-s) was isolated as per literature from P. integrifolia and focused first time as standard bioactive marker for quantification. Developed mobile phase Toluene: Acetone: Diethylamine (7:2:1) for Pr-S gave Rf 0.59 at λ max 283 nm in densitometric scan, focused for specificity, fingerprint and estimation study in PI-AK and selected formulation successively. Linearity assessed in range of 8 to 16 μg /band with regression coefficient of 0.9983, LOD 0.742 μg/Band, LOQ 2.225, also robust for Pr-S. Accuracy for % recovery performed on extract as well on formulation, further subjected for precision study with application one way ANOVA for finding F value, found within limit therefore no significance of variance. A rapid and selective HPTLC method shows good linearity, recovery and high precision, useful method for analysis of Pr-S and as quality control parameter for raw material as well formulation as per foremost need of WHO, FDA and Pharmacopoeia.
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