Development and Validation of UV Spectroscopic Method for Determination of Canagliflozin in Bulk and Pharmaceutical Dosage Form

Ishpreet Kaur, S. Wakode, H. Singh
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引用次数: 35

Abstract

Objective: To develop and validate simple, sensitive, precise, rapid and cost effective method for determination of Canagliflozin in bulk and pharmaceu tical formulations as per ICH Guidelines. Methods: A simple double beam UV Spectrophotometric method has been developed and validated with different parameters such as Linearity, Precision, Repeatability, Limit of Detection (LOD), Limit of Quantification (LOQ), Accuracy, Robustness and Rug gedness. Results: Canagliflozin in methanol shows maximum absorbance at 290 nm. Beer’s law was obeyed in the concentration range of 5-10 mcg mL1, The LOD and LOQ were found to be 0.084 mcg/ml and 0.255 mcg/ml respectively. A recovery of Canagliflozin in tablet formulation was observed in the range of 80.00-120.00%. Percentage assay of Canagliflozin tablets (INVOKANA ® ) was found to be more than 99%. Conclusion: The proposed
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紫外光谱法测定加格列净原料药和制剂含量的建立与验证
目的:根据ICH指南,建立并验证简便、灵敏、精确、快速、经济高效的原料药和制剂加格列净含量测定方法。方法:建立了一种简单的双光束紫外分光光度法,并对其进行了线性度、精密度、重复性、检出限、定量限、准确度、鲁棒性和稳健性等参数的验证。结果:加格列净在甲醇中的吸光度在290 nm处最大。在5 ~ 10微克/毫升的浓度范围内符合比尔定律,定量限和定量限分别为0.084微克/毫升和0.255微克/毫升。加格列净片剂的回收率为80.00 ~ 120.00%。卡格列净片(INVOKANA®)的百分含量大于99%。结论:提出
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