An Innovative Stability Indicating RP-HPLC Assay Method for theDetermination of Caroverine in Pharmaceutical Bulk and Tablets

A. Raza, Ansari Tm
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Abstract

An innovative, quick and easy reversed phase high performance liquid chromatographic method is elaborated and authenticated for the quantitative determination of caroverine in pharmaceutical bulk material and tablets. Shimpack CLC-ODC (C18) column was used. The mobile phase acetonitrile and buffer solution (30:70) pH 4.9 is transmitted at a flow rate of 1 mL/min. The eluent was observed using UV detector at 225 nm. The recent developed RP-HPLC method is specific, accurate, precise and linear (R2>0.998) within the range of 2-150 μg/mL concentration. The limit of detection and quantification is 0.068 μg/mL and 0.201 μg/mL respectively. The newly proposed method is applied to determine caroverine in pharmaceutical tablet formulations. The developed method is optimized using samples generated by forced degradation studies. Results of analysis are validated statistically. The method was selective, precise, accurate and can be used for routine analysis of caroverine in quality control laboratories of pharmaceutical industries.
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一种新型稳定性指示反相高效液相色谱法测定原料药和片剂中胡萝卜碱的含量
建立了一种快速简便的反相高效液相色谱法定量测定药用原料药和片剂中胡萝卜碱的方法。色谱柱为shipackc - odc (C18)柱。流动相乙腈和缓冲溶液(30:70)pH 4.9以1ml /min的流速传输。用紫外检测器在225 nm处观察洗脱液。该方法在2 ~ 150 μg/mL浓度范围内特异性强、准确度高、精密度好,线性关系良好(R2>0.998)。检测限为0.068 μg/mL,定量限为0.201 μg/mL。该方法可用于片剂中卡罗弗碱的测定。利用强制降解研究生成的样品对所开发的方法进行了优化。分析结果经统计学验证。该方法选择性好,精密度高,准确度高,可用于制药企业质控实验室中卡罗弗碱的常规分析。
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