DEVELOPMENT OF ANALYTICAL METHOD AND ITS VALIDATION FOR SILDENAFIL CITRATE BY UV-SPECTROPHOTOMETRY

D. Tomar, Peeyush Kaushik, Ashish Mishra, Lalan Kumar Sah
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Abstract

bulk drugs and the drug formulations and its validation. Method: The ideal conditions were established for the investigation or analysis of the drug. Results: The λmax of 293.2nmwas found for the Sildenafil citrate. Within, 8 to 60μg/ml concentration range the method complied with Beer's Law and show exceptional sensitivity with linearity. Moreover, 1.012 and 3.036 were observed limit of detection and quantification, respectively. When the absorbance versus concentration graph was plotted on the calibration curves a linear relationship was observed with the coefficient correlation of 0.99. The observed regression coefficient (Y) of the calibration curves was found to be 0.0131x- 0.0191. The method was precise and accurate with the experiential value of 2.0325± 0.044. The stability of the test solution was up to 48 hours. Conclusion: The proposed analytical method is simple, economical and experimentally less time-consuming. Therefore, it will be appropriate for Sildenafil citrate analysis of pharmaceutical formulations in bulk.
枸橼酸西地那非紫外分光光度分析方法的建立及验证
原料药、制剂及其验证。方法:为该药物的调查或分析建立了理想的条件。结果:枸橼酸西地那非的λmax为293.2nm。在8 ~ 60μg/ml浓度范围内,该方法符合比尔定律,具有良好的线性敏感性。检出限为1.012,定量限为3.036。在标定曲线上绘制吸光度-浓度曲线,两者呈线性关系,相关系数为0.99。校正曲线的回归系数(Y)为0.0131x- 0.0191。方法精密度高,准确度为2.0325±0.044。测试溶液的稳定性可达48小时。结论:该方法简便、经济、实验时间短。因此,它将适用于散装药物制剂的柠檬酸西地那非分析。
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