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Development and Validation of UV Spectrophotometric Method for the Determination of Pazopanib Hydrochloride in Pharmaceutical Dosage Form

机译:紫外分光光度法测定药物剂型盐酸吡喃盐酸盐的开发与验证

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摘要

A precise, accurate, simple, cost effective, the ultraviolet spectrophotometric method has been developed for the determination of Pazopanib hydrochloride in the Pharmaceutical dosage form. Pazopanib hydrochloride shows the highest λmax at 273 nm. The Pazopanib hydrochloride follows linearity in the concentration range of 2-10 μg /mL with a decorous correlation coefficient value of 0.999. The precision of the method was studied as an intra-day and inter-day study. The % RSD value is < 2, which indicates that the process is precise. The % recovery was found to be in the range lies between 99.27 - 101.38 %. The percentage assay of Pazopanib hydrochloride (Votrient) obtained was 99.445 %. The Proposed spectrophotometric method was validated as per the ICH Q2 (R1) guidelines. The proposed UV method is accurate, precise and reproducible. Hence this rapid method can be viable for the quality control analysis of Pazopanib hydrochloride in the pharmaceutical dosage form.
机译:已经开发了精确,准确,简单,成本效果的紫外分光光度法,用于测定药物剂型中的Pazopanib盐酸盐。 Pazopanib盐酸盐显示出273nm的最高λmax。 Pazopanib盐酸盐在2-10μg/ ml的浓度范围内跟随线性,具有0.999的致命相关系数值。该方法的精确度是在日内和日间研究中进行的。 %RSD值为<2,表示该过程精确。发现%回收率在于99.27-101.38%之间的范围。获得的pazopanib盐酸盐(紫烷)的百分比测定为99.445%。根据ICH Q2(R1)指南,验证了所提出的分光光度法。所提出的UV方法是准确的,精确和可重复的。因此,这种快速方法可以在药物剂型中对Pazopanib盐酸盐的质量控制分析可行。

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