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首页> 外文期刊>Journal of Young Pharmacists >Stability Indicating HPTLC Determination of Triamcinalone Acetonide in Bulk Drug and Sterile Injectable Suspension
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Stability Indicating HPTLC Determination of Triamcinalone Acetonide in Bulk Drug and Sterile Injectable Suspension

机译：稳定度表明HPTLC测定散装药物和无菌注射剂悬浮液中曲安西酮的乙内酰胺

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摘要

A sensitive, accurate, precise and stability indicating high-performance thin layer chromatographic method was developed and validated for analysis of triamcinalone acetonide (TRIA) in bulk drug and sterile injectable suspension. The method employed HPTLC aluminum precoated plates with silica gel 60F-254 as the stationary phase. The solvent system consisted of Toluene: ethyl acetate: ammonia solution (33:67:0.1 %v/v). This system was found to give compact bands for TRIA (Rf value 0.38 ± 0.02). TRIA was subjected to acid, alkali and neutral hydrolysis, oxidation, sun light and dry heat treatment. The degraded products were well separated from the pure drug with notably different Rf values. CAMAG semi-automatic HPTLC used for the analysis. Densitometric analysis of TRIA was carried out in the absorbance mode at 240 nm. The linear regression data for the calibration plots showed good linear relationship with correlation coefficient 0.9996 ±/ 0.001 in the concentration range of 100.0-2000.0 ng spot-1. The values of slope and intercept were 9.7841 and -86.13 respectively. The method was validated for precision, accuracy, robustness, and recovery. The limits of detection and quantitation were 33.0 and 100.0 ng spot-1 respectively. As the method could effectively separate the drug from its degradation products, it can be employed as a routine stability indicating assay method.
机译：开发了一种灵敏，准确，精确和稳定的指示性高效薄层色谱方法，并经过验证可用于分析散装药物和无菌注射混悬液中的曲安霉素丙酮（TRIA）。该方法使用HPTLC铝预涂板，硅胶60F-254作为固定相。溶剂体系由甲苯：乙酸乙酯：氨溶液（33∶67∶0.1％v / v）组成。发现该系统给出了TRIA的紧凑谱带（R f 值0.38±0.02）。 TRIA经过酸，碱和中性水解，氧化，日光和干热处理。降解产物与纯药物分离良好，R 值明显不同。 CAMAG半自动HPTLC用于分析。 TRIA的光密度分析在240 nm的吸光度模式下进行。校正图的线性回归数据在100.0-2000.0 ng spot -1 浓度范围内具有良好的线性关系，相关系数为0.9996±/ 0.001。斜率和截距的值分别为9.7841和-86.13。验证了该方法的准确性，准确性，鲁棒性和回收率。检测限和定量限分别为33.0和100.0 ng spot -1 。由于该方法可以有效地将药物与其降解产物分离，因此可以用作常规稳定性指示测定方法。

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