Singh Shipra, Mishra Amrita, Verma Anurag, Ghosh Ashoke K, Mishra Arun K
Department of Pharmaceutical Chemistry, Central Facility of Instrumentation, College of Pharmacy, IFTM Lodipur-Rajput, Moradabad, India.
J Adv Pharm Technol Res. 2012 Oct;3(4):237-40. doi: 10.4103/2231-4040.104715.
The present study was undertaken to develop a validated, rapid, simple, and low-cost ultraviolet (UV) spectrophotometric method for estimating Etoricoxib (ETX) in pharmaceutical formulations. The analysis was performed on λ max 233 nm using 0.1 M HCl as blank/diluent. The proposed method was validated on International Conference on Harmonization (ICH) guidelines including parameters as linearity, accuracy, precision, reproducibility, and specificity. The proposed method was also used to access the content of the ETX in two commercial brands of Indian market. Beer's law was obeyed in concentration range of 0.1-0.5 μg/ml, and the regression equation was Y = 0.418x + 0.018. The mean accuracy values for 0.1 μg/ml and 0.2 μg/ml concentration of ETX were found to be 99.76 ± 0.52% and 99.12 ± 0.84, respectively, and relative standard deviation (RSD) of interday and intraday was less than 2%. The developed method was suitable and specific to the analysis of ETX even in the presence of common excipients. The method was applied on two different marketed brands and ETX contents were 98.5 ± 0.56 and 99.33 ± 0.44, respectively, of labeled claim. The proposed method was validated as per ICH guidelines and statistically good results were obtained. This method can be employed for routine analysis of ETX in bulk and commercial formulations.
本研究旨在开发一种经过验证的、快速、简单且低成本的紫外(UV)分光光度法,用于测定药物制剂中的依托考昔(ETX)。使用0.1 M盐酸作为空白/稀释剂,在233 nm的最大波长处进行分析。所提出的方法依据国际协调会议(ICH)指南进行了验证,包括线性、准确度、精密度、重现性和特异性等参数。所提出的方法还用于检测印度市场上两个商业品牌中ETX的含量。在0.1 - 0.5 μg/ml的浓度范围内符合比尔定律,回归方程为Y = 0.418x + 0.018。发现ETX浓度为0.1 μg/ml和0.2 μg/ml时的平均准确度值分别为99.76 ± 0.52%和99.12 ± 0.84,日间和日内的相对标准偏差(RSD)均小于2%。所开发的方法即使在存在常见辅料的情况下也适用于ETX的分析且具有特异性。该方法应用于两个不同的市售品牌,ETX含量分别为标示量的98.5 ± 0.56和99.33 ± 0.44。所提出的方法按照ICH指南进行了验证,并获得了统计学上的良好结果。该方法可用于批量和商业制剂中ETX的常规分析。