A validated stability-indicating TLC method for determination of forskolin in crude drug and pharmaceutical dosage form
A validated stability-indicating TLC method for determination of forskolin in crude drug and pharmaceutical dosage form
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DOI：
10.1365/s10337-008-0521-x
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发表时间：
2008-03-01
期刊：
影响因子：
1.7
通讯作者：
Aquil, Mohd.
中科院分区：
文献类型：
--
作者：
Ahmad, Sayeed;Rizwan, Mohd.;Aquil, Mohd.
建立了一种简便、准确、选择性好、精密度高、经济、稳定性好的毛喉素原料药和制剂中毛喉素的高效薄层色谱分析方法。方法在涂有硅胶60 F-254的薄层铝板上，以苯：甲醇（9：1，v/v）为溶剂，得到毛喉素的致密斑点（R-f值0.25 ± 0.02）。在用茴香醛硫酸喷雾后，在545 nm处以吸光度模式进行毛喉素的光密度分析。校准图的线性回归分析数据显示，在100- 1，000 ng/斑点的浓度范围内，峰高和峰面积的线性关系良好，r分别为0.994和0.994。检测限和定量限分别为8.1和26.9 ng/斑点。该方法用于毛喉鞘蕊花根和胶囊剂中毛喉素的测定，结果表明毛喉素的含量分别为0.18和0.57%w/w。毛喉素经历酸和碱水解、氧化、光降解和热降解。观察到药物易受酸、碱水解、氧化、光氧化和热降解。经统计学分析证明，该方法重复性好、选择性好、准确度高，可用于毛喉素原料药及制剂中毛喉素的含量测定。所建立的方法有效地将毛喉素从C.毛喉素的降解产物，因此，它可以用于常规分析和作为稳定性指示方法。
A simple, accurate, selective, precise, economical and stability-indicating high-performance thin-layer chromatographic method for analysis of forskolin in crude drug and in pharmaceutical dosage form was developed and validated. The method was developed on TLC aluminium plates precoated with silica gel 60F-254 using solvent system benzene:methanol (9:1, v/v), which gives compact spot of forskolin (R-f value 0.25 +/- 0.02). Densitometric analysis of forskolin was carried out in the absorbance mode at 545 nm after spraying with anisaldehyde sulphuric acid. The linear regression analysis data for the calibration plots showed good linear relationship with r = 0.994 and 0.994 with respect to peak height and peak area, respectively, in the concentration range 100-1,000 ng per spot. The limits of detection and quantification were 8.1 and 26.9 ng per spot, respectively. The proposed method was applied for determination of forskolin in Coleus forskohlii root and in capsule dosage forms, which showed 0.18 and 0.57% w/w of forskolin. Forskolin was subjected to acid and alkali hydrolysis, oxidation, photodegradation and heat degradation. It was observed that the drug is susceptible to acid, base hydrolysis, oxidation, photo-oxidation and heat degradation. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of forskolin in crude drug and in pharmaceutical dosage forms. The developed method effectively resolved the forskolin from components of C. forskohlii root, from excipients of capsule as well as the degradation products of forskolin hence, it can be employed for routine analysis and as a stability-indicating method.