SIMPLE COST-EFFECTIVE STABILITY INDICATING METHOD FOR THE ESTIMATION OF AVANAFIL IN BULK OR FORMULATION BY RP-HPLC

Pankaj Kadwe, D. Basedia, V. Thakur, B. K. Dubey
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Abstract

This research presents a comprehensive analytical approach for the estimation of avanafil, a phosphodiesterase type 5 (PDE5) inhibitor used in the treatment of erectile dysfunction. The developed method utilizes Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) and focuses on stability indication, linearity, precision, and robustness. System suitability parameters, linearity, recovery studies, and forced degradation studies were conducted to validate the method's efficacy. The results indicate a reliable and cost-effective approach for the estimation of avanafil in both bulk and pharmaceutical formulations. The method demonstrates sensitivity, precision, and stability-indicating characteristics, making it a valuable tool for routine quality control processes in the pharmaceutical industry.
用 rp-hplc 法估测散装或制剂中的阿伐那非的简便、经济、稳定的指示方法
本研究提出了一种估算阿伐那非的综合分析方法,阿伐那非是一种用于治疗勃起功能障碍的5型磷酸二酯酶(PDE5)抑制剂。所开发的方法采用反相高效液相色谱法(RP-HPLC),重点关注稳定性指示、线性、精密度和稳健性。为验证该方法的有效性,还进行了系统适用性参数、线性、回收率研究和强制降解研究。结果表明,该方法既可靠又经济,可用于估算散装和药物制剂中的阿伐那非。该方法具有灵敏度高、精确度高、稳定性好等特点,是制药行业常规质量控制流程的重要工具。
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