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用于采用分光光度法对氯诺昔康原料药及其片剂剂型进行方法开发与验证的共沸混合物。

Azeotropic mixture used for development and validation of Lornoxicam in bulk and its tablet dosage form by spectrophotometric method.

作者信息

Prajapati Prajesh, Vaghela Vipul, Rawtani Deepak, Patel Harshad, Kubavat Jasmin, Baraiya Dharmendra

机构信息

Department of Pharmaceutical Analysis, Institute of Research and Development, Gujarat Forensic Sciences University, Sector-18A, Nr. Police bhavan, Gandhinagar 382007, Gujarat, India.

A.R. College of Pharmacy and G.H. Patel Institute of Pharmacy, Vallabh Vidyanagar 388120, Gujarat, India.

出版信息

J Pharm Anal. 2012 Aug;2(4):306-309. doi: 10.1016/j.jpha.2012.02.004. Epub 2012 Feb 28.

Abstract

A novel, safe, economic and sensitive method of spectrophotometric estimation has been developed using Azeoptropic mixture (water:methanol: 60:40, v/v) for the quantitative determination of Lornoxicam, a practically water-insoluble drug. Hence, Lornoxicam stock solution was prepared in Azeoptropic mixture. Lornoxicam showed maximum absorbance at 383 nm. Beer's law was obeyed in the concentration range 4-24 μg/mL with regression coefficient of 0.999. The method was validated in terms of linearity (=0.999), precision (CV for intra-day and inter-day was 0.28-0.68 and 0.12-0.92, respectively), accuracy (98.03-100.59% w/w) and specificity. This method is simple, precise, accurate, sensitive and reproducible and can be used for the routine quality control testing of the marketed formulations.

摘要

已开发出一种新颖、安全、经济且灵敏的分光光度法估算方法,该方法使用共沸混合物(水:甲醇:60:40,v/v)对洛索洛芬(一种几乎不溶于水的药物)进行定量测定。因此,在共沸混合物中制备了洛索洛芬储备溶液。洛索洛芬在383 nm处显示出最大吸光度。在4 - 24 μg/mL的浓度范围内符合比尔定律,回归系数为0.999。该方法在线性(=0.999)、精密度(日内和日间的CV分别为0.28 - 0.68和0.12 - 0.92)、准确度(98.03 - 100.59% w/w)和专属性方面得到了验证。该方法简单、精密、准确、灵敏且可重现,可用于市售制剂的常规质量控制检测。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/86d6/5760915/415e142e5e65/gr1.jpg

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