PRELIMINARY VALIDATION OF UV SPECTROPHOTOMETRIC FOR DETERMINATION OF ANTIEMETIC DRUG APREPITANT IN BULK FORM

A. Kumari, Parminderjit Kaur
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Abstract

Objective: The main objective of this work was to put forth the assorted strategies to develop and validate a novel, specific, precise and reliable method for estimation of aprepitant in bulk using UV-visible spectroscopy method. Method: The validation of Aprepitant was done by using UV-visible spectrophotometric method by using double beam systronics UV-visible spectrometer, model UV-2201 (India). The validation method involves various parameters like linearity, precision, accuracy, robustness, ruggedness, detection, quantification limits of formulation analysis according to International Conference on Harmonization (ICH) guidelines. Results: UV-spectroscopic determination was carried out at maximum absorption 263.6nm using pH 6.8 buffer & 1.1% tween 80 and 263.8nm using methanol and distilled water. The method obeyed Beer Lambert’s Law in the concentration range of 8-48µg/ml and R2 was found to be 0.999. Conclusion: As per the results were concerned, the %RSD was found to be less than 2% which is compliance with the acceptance criteria of Q1 (R1) and According to results, the currently developed method shows compliance with acceptance criteria with Q1 (R1) and international conference on harmonization (2005) guidelines. Thus, the developed method was found to be simple accurate and précised.
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紫外分光光度法测定止吐药阿瑞吡坦散装含量的初步验证
目的:为建立一种新颖、特异、精确、可靠的紫外可见光谱法定量测定阿瑞吡坦的方法,提出了相应的策略。方法:采用紫外可见分光光度法对阿瑞吡坦进行验证,采用双光束系统紫外可见光谱仪,型号为UV-2201(印度)。验证方法涉及各种参数,如线性,精密度,准确度,鲁棒性,坚固性,检测,定量限制,根据国际统一会议(ICH)指南的制剂分析。结果:用pH 6.8的缓冲液,80 ~ 263.8nm之间1.1%的甲醇和蒸馏水,在最大吸收峰263.6nm处进行了紫外光谱测定。该方法在8 ~ 48µg/ml浓度范围内符合比尔-朗伯定律,R2为0.999。结论:根据结果,RSD %小于2%,符合Q1 (R1)的验收标准。根据结果,目前开发的方法符合Q1 (R1)和国际协调会议(2005)指南的验收标准。结果表明,该方法简单、准确、简便。
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