Development and Validation of UV Spectroscopic Method For Estimation Of Lansoprazole In Capsule Dosage Form

Harshal S. Pawar, Madhuri A. Bhole, S. Patil, Kalpesh V. Sonar
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Abstract

ABSTRACT To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Lansoprazole in Capsule dosage form. The drug is soluble in analytical grade Methanol. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics. It showed absorption maxima were determined in analytical grade Methanol. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Lansoprazole in Capsule dosage form and also validated as per ICH guidelines. The drug is freely soluble in Dimethylformamide, soluble in analytical grade Methanol, sparingly soluble in Ethanol, slightly soluble in Ethyl Acetate, Dichloromethane and Acetonitrile. So, the analytical grade Methanol is used as a diluent in method. The melting point of Lansoprazole was found to be 179-180 ̊C (uncorrected). It showed absorption maxima 285 nm in analytical grade Methanol. On the basis of absorption spectrum the working concentration was set on 10μg/ml (PPM). The linearity was observed between 6-14 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 99.00 and 100.80 % for three levels respectively. The % RSD for precision was found to be 0.9039 %.A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Lansoprazole in Capsule dosage form. The method could be considered for the determination of Lansoprazole in quality control laboratories.
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紫外光谱法测定兰索拉唑胶囊剂型的建立与验证
建立并验证一种简便、快速、线性、准确、精确、经济的兰索拉唑胶囊剂型紫外光谱测定方法。该药物可溶于分析级甲醇。该药物是根据溶解度研究和熔点在设备熔点仪上完成的基础上确定的。结果表明,在分析级甲醇中测定了吸光度最大值。药物浓度与吸光度呈良好的线性关系,符合比尔定律。建立了兰索拉唑胶囊剂型的紫外光谱测定方法,并根据ICH指南进行了验证。本品易溶于二甲基甲酰胺,易溶于分析级甲醇,微溶于乙酸乙酯、二氯甲烷和乙腈。因此,该方法采用分析级甲醇作为稀释剂。兰索拉唑熔点为179 ~ 180℃(未校正)。在分析级甲醇中最大吸收波长为285 nm。根据吸收光谱确定其工作浓度为10μg/ml (PPM)。在6 ~ 14 μg/ml (PPM)之间呈线性关系。分析结果通过回收率研究得到验证。三个水平的回收率分别为98.75、99.00和100.80%。精密度的RSD为0.9039%。建立了一种简便、快速、线性、准确、精确、经济的兰索拉唑胶囊剂型紫外光谱测定方法。该方法可作为质量控制实验室中兰索拉唑的测定方法。
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