Development and validation of UV-spectrophotometric methods for quantitative estimation of Prothionamide in pure and pharmaceutical dosage forms

S. Debnath, S. Saisivam, Dillip Kumar Dash, M. Debnath
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引用次数: 6

Abstract

UV Spectrophotometric method was developed and validated for the quantitative determination of Prothionamide in bulk drug and in pharmaceutical formulations. Prothionamide shows the maximum absorbance at 288 nm in phosphate buffer (pH 7.4). Prothionamide follows Beer’s law in the concentration range of 4-20 µg/ml ( r 2 = 0.999). The detection limit (DL) and quantitation limit (QL) were 0.406 and 1.229 µg/ml respectively. Accuracy and precision were found to be satisfactory. The developed methods were validated according to ICH guidelines. All the validation parameters were found to be satisfactory accordance with the standard values. Therefore, the proposed method can be used for routine practice for the determination of Prothionamide in assay of bulk drug and pharmaceutical formulations. International Current Pharmaceutical Journal, June 2015, 4(7): 402-404
紫外分光光度法测定纯剂型和药用剂型中丙硫胺含量的方法的建立和验证
建立并验证了紫外分光光度法定量测定原料药和制剂中丙硫胺含量的方法。在pH 7.4的磷酸盐缓冲液中,丙硫酰胺在288 nm处的吸光度最大。Prothionamide在4 ~ 20µg/ml浓度范围内符合Beer定律(r 2 = 0.999)。检出限(DL)为0.406,定量限(QL)为1.229µg/ml。准确度和精密度均令人满意。根据ICH指南对所开发的方法进行了验证。所有验证参数均符合标准值。因此,该方法可用于原料药和制剂中丙硫胺含量的常规测定。国际药学杂志,2015,4(7):402-404
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