A NEW RP-HPLC METHOD FOR ESTIMATION OF VERICIGUAT IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORM

P. Pravalika, G. Jephthah, A. R. Reddy, T. R. Rao
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Abstract

A simple, rapid, specific and accurate reverse phase high performance liquid chromatographic method has beendeveloped for the validation of Vericiguat in bulk as well as in marketed pharmaceutical dosage form. This separation wasperformed on a Symmetry ODS C18 (4.6×250mm, 5μm) column with Methanol:Phosphate Buffer (55:45) v/v asmobile phase at a flow rate of 1.0 mL min−1 with UV detection at 225 nm; the constant column temperature wasambient. The run time under these chromatographic conditions was less than 8 min. The retention time of Vericiguatwas found to be 2.252. The calibration plot was linear over the concentration range of 6 - 14 μg mL−1 with limits ofdetection and quantification values of 1.2 and 3.6 μg mL−1 respectively. The mean % assay of marketed formulation wasfound to be 99.86%, and % recovery was observed in the range of 98-102%. Relative standard deviation for theprecision study was found <2%. The developed method was simple, precise, specific, accurate and rapid, making itsuitable for estimation of Vericiguat in bulk and marketed pharmaceutical dosage form dosage form.
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一种新的 RP-HPLC 方法用于估算散装药物和药物剂型中的 vericiguat
本研究开发了一种简单、快速、特异和准确的反相高效液相色谱法,用于验证散装和上市药物剂型中的维力群。采用 Symmetry ODS C18 (4.6×250mm, 5μm) 色谱柱,以甲醇:磷酸盐缓冲液 (55:45) v/v 为流动相,流速为 1.0 mL min-1,紫外检测波长为 225 nm,柱温为室温。在此色谱条件下的运行时间小于 8 分钟。维力胶囊的保留时间为 2.252。在 6 - 14 μg mL-1 的浓度范围内线性关系良好,检测限和定量限分别为 1.2 μg mL-1 和 3.6 μg mL-1。市售制剂的平均检测率为 99.86%,回收率为 98-102%。精密度研究的相对标准偏差小于 2%。所建立的方法简便、精确、特异、准确、快速,适用于散装和市售药物制剂中维力吉曲的测定。
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