Jain P S
R.C. Patel College of Pharmacy, Karwand Naka, Shirpur Dist. Dhule 425 405 (M.S.) India.
J Chromatogr Sci. 2010 Jan;48(1):45-8. doi: 10.1093/chromsci/48.1.45.
A simple, selective, precise, and stability-indicating high-performance thin-layer chromatographic (HPTLC) method for the analysis of ambroxol hydrochloride both as a bulk drug and in formulations was developed and validated. The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of methanol-triethylamine (4:6 v/v). The system was found to give a compact spot for ambroxol hydrochloride (R(f) value of 0.53 +/- 0.02). Densitometric analysis of ambroxol hydrochloride was carried out in the absorbance mode at 254 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r(2) = 0.9966 +/- 0.0013 with respect to peak area in the concentration range 100-1000 ng/spot. The mean value +/- standard deviation of slope and intercept were 164.85 +/- 0.72 and 1168.3 +/- 8.26 with respect to peak area. The method was validated for precision, recovery, and robustness. The limits of detection and quantitation were 10 and 30 ng/spot, respectively. Ambroxol hydrochloride was subjected to oxidation and thermal degradation. The drug undergoes degradation under oxidation and heat conditions. This indicates that the drug is susceptible to oxidation and heat. Statistical analysis proves that the method is repeatable, selective, and accurate for the estimation of said drug. Stability indicating of new chemical entities is an important part for the drug development of ambroxol hydrochloride and for its estimation in plasma and other biological fluids; the novel Statistical analysis proves that the method is repeatable and selective for the analysis of ambroxol hydrochloride as bulk drug and in pharmaceutical formulations. The proposed developed HPTLC method can be applied for identification and quantitative determination of ambroxol hydrochloride in bulk drug and dosage forms. This work is to determine the purity of the drug available from the various sources by detecting the related impurities.
建立并验证了一种简单、选择性强、精确且具有稳定性指示作用的高效薄层色谱（HPTLC）方法，用于分析盐酸氨溴索原料药及其制剂。该方法采用预涂硅胶60F - 254的HPTLC铝板作为固定相。溶剂系统由甲醇 - 三乙胺（4:6 v/v）组成。结果发现该系统能为盐酸氨溴索给出一个致密斑点（R(f)值为0.53±0.02）。在254 nm波长下以吸光度模式对盐酸氨溴索进行光密度分析。校准曲线的线性回归分析数据显示，在100 - 1000 ng/斑点的浓度范围内，峰面积与r(2)=0.9966±0.0013具有良好的线性关系。相对于峰面积，斜率和截距的平均值±标准差分别为164.85±0.72和1168.3±8.26。该方法在精密度、回收率和耐用性方面得到了验证。检测限和定量限分别为10和30 ng/斑点。对盐酸氨溴索进行了氧化和热降解实验。该药物在氧化和加热条件下会发生降解。这表明该药物易受氧化和热的影响。统计分析证明该方法对于所述药物的测定具有可重复性、选择性和准确性。新化学实体的稳定性指示是盐酸氨溴索药物开发及其在血浆和其他生物流体中测定的重要组成部分；新颖的统计分析证明该方法对于盐酸氨溴索原料药及其制剂的分析具有可重复性和选择性。所提出的HPTLC方法可用于盐酸氨溴索原料药和剂型的鉴别和定量测定。这项工作旨在通过检测相关杂质来确定从各种来源获得的药物的纯度。
