用于测定固定剂量复方抗逆转录病毒药物的导数分光光度法。
Derivative spectrophotometric method for estimation of antiretroviral drugs in fixed dose combinations.
作者信息
P B Mohite, R B Pandhare, S G Khanage
机构信息
Department of Pharmaceutical Chemistry, MES's College of Pharmacy, Sonai, Ahmednagar, Maharashtra, India.
出版信息
Adv Pharm Bull. 2012;2(1):115-8. doi: 10.5681/apb.2012.016. Epub 2012 Apr 20.
PURPOSE
Lamivudine is cytosine and zidovudine is cytidine and is used as an antiretroviral agents. Both drugs are available in tablet dosage forms with a dose of 150 mg for LAM and 300 mg ZID respectively.
METHOD
The method employed is based on first order derivative spectroscopy. Wavelengths 279 nm and 300 nm were selected for the estimation of the Lamovudine and Zidovudine respectively by taking the first order derivative spectra. The conc. of both drugs was determined by proposed method. The results of analysis have been validated statistically and by recovery studies as per ICH guidelines.
RESULT
Both the drugs obey Beer's law in the concentration range 10-50 μg mL-1,for LAM and ZID; with regression 0.9998 and 0.9999, intercept - 0.0677 and - 0.0043 and slope 0.0457 and 0.0391 for LAM and ZID, respectively.The accuracy and reproducibility results are close to 100% with 2% RSD.
CONCLUSION
A simple, accurate, precise, sensitive and economical procedures for simultaneous estimation of Lamovudine and Zidovudine in tablet dosage form have been developed.
目的
拉米夫定是胞嘧啶，齐多夫定是胞苷，二者均用作抗逆转录病毒药物。两种药物均有片剂剂型，拉米夫定剂量为150毫克，齐多夫定剂量为300毫克。
方法
采用的方法基于一阶导数光谱法。通过获取一阶导数光谱，分别选择279纳米和300纳米波长来测定拉米夫定和齐多夫定。用所提出的方法测定两种药物的浓度。分析结果已按照ICH指南进行了统计学验证和回收率研究。
结果
两种药物在10 - 50微克/毫升浓度范围内均符合比尔定律，拉米夫定和齐多夫定的回归系数分别为0.9998和0.9999，截距分别为 - 0.0677和 - 0.0043，斜率分别为0.0457和0.0391。准确度和重现性结果接近100%，相对标准偏差为2%。
结论
已开发出一种简单、准确、精密、灵敏且经济的方法，用于同时测定片剂剂型中的拉米夫定和齐多夫定。
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