Development and Validation of UV Spectroscopic Method for Simultaneous Estimation of Remogliflozin Etabonate and Vildagliptin in bulk and Pharmaceutical Dosage Form

Vashi Dhara, Chaudhari Hetvi
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Abstract

A new, simple, precise, accurate, reproducible, and efficient UV spectroscopic method was developed and validated for simultaneous estimation of Remogliflozin Etabonate and Vildagliptin in pure and pharmaceutical dosage form. The 𝜆max of Remogliflozin Etabonate and Vildagliptin in Methanol were found to be 236nm and 215nm, respectively. Calibration curves of Remogliflozin Etabonate and Vildagliptin were found to be linear in the concentration ranges of 5-25µg/mL and 1-5µg/mL with their correlation coefficient values (R2) 0.9993 and 0.9998, respectively. LOD and LOQ were found to be 0.0246µg/mL and 0.0745µg/mL for Remogliflozin Etabonate and 0.0278µg/mL and 0.0842µg/mL for Vildagliptin, respectively. In the precision study, the % RSD value was found within limits (RSD < 2%). The percentage recovery at various concentration levels varied from 99.25 to 101.06% for Remogliflozin Etabonate and 99.58 to 100.41% for Vildagliptin, respectively. The proposed method can be applied successfully for the simultaneous estimation of Remogliflozin Etabonate and Vildagliptin in pure and pharmaceutical dosage form. In this method simultaneous equation method was applied to find assay of both drugs in pharmaceutical dosage form.
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紫外光谱法同时测定原料药和制剂中瑞格列净和维格列汀含量的建立与验证
建立了一种简便、精确、准确、重现性好、高效的紫外分光光度法,用于同时测定制剂制剂和制剂制剂remgliflozin Etabonate的含量。remgliflozin Etabonate和Vildagliptin在甲醇中的𝜆max分别为236nm和215nm。在5 ~ 25µg/mL和1 ~ 5µg/mL范围内,瑞格列净和维格列汀的校准曲线呈良好的线性关系,相关系数(R2)分别为0.9993和0.9998。regliflozin Etabonate的LOD和LOQ分别为0.0246µg/mL和0.0745µg/mL, Vildagliptin的LOD和LOQ分别为0.0278µg/mL和0.0842µg/mL。在精密度研究中,发现% RSD值在限定范围内(RSD < 2%)。在不同浓度下,瑞格列净的回收率为99.25 ~ 101.06%,维格列汀的回收率为99.58 ~ 100.41%。该方法可成功地同时测定制剂制剂和纯制剂remgliflozin Etabonate和维格列汀的含量。本方法采用联立方程法对两种药物的剂型进行测定。
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