Dafale Nishant A, Semwal Uttam P, Agarwal Piyush K, Sharma Pradeep, Singh G N
Microbiology Division, Indian Pharmacopoeia Commission, Ghaziabad 201 001, India.
J Pharm Anal. 2015 Feb;5(1):18-26. doi: 10.1016/j.jpha.2014.07.007. Epub 2014 Jul 21.
The aim of this study was to develop and validate a simple, sensitive, precise and cost-effective one-level agar diffusion (5+1) bioassay for estimation of potency and bioactivity of Levofloxacin in pharmaceutical preparation which has not yet been reported in any pharmacopoeia. Among 16 microbial strains, ATCC-14884 was selected as the most significant strain against Levofloxacin. Bioassay was optimized by investigating several factors such as buffer pH, inoculums concentration and reference standard concentration. Identification of Levofloxacin in commercial sample Levoflox tablet was done by FTIR spectroscopy. Mean potency recovery value for Levofloxacin in Levoflox tablet was estimated as 100.90%. A validated bioassay method showed linearity (=0.988), precision (Interday RSD=1.05%, between analyst RSD=1.02%) and accuracy (101.23%, RSD=0.72%). Bioassay was correlated with HPLC using same sample and estimated potencies were 100.90% and 99.37%, respectively. Results show that bioassay is a suitable method for estimation of potency and bioactivity of Levofloxacin pharmaceutical preparations.
本研究的目的是开发并验证一种简单、灵敏、精确且经济高效的一级琼脂扩散（5 + 1）生物测定法，用于评估左氧氟沙星在药物制剂中的效价和生物活性，这在任何药典中均未见报道。在16种微生物菌株中，ATCC - 14884被选为对左氧氟沙星最敏感的菌株。通过研究缓冲液pH值、接种物浓度和参考标准浓度等多个因素对生物测定法进行了优化。采用傅里叶变换红外光谱法（FTIR）对市售左氧氟沙星片剂中的左氧氟沙星进行了鉴定。左氧氟沙星片剂中左氧氟沙星的平均效价回收率估计为100.90%。一种经过验证的生物测定法显示出线性（= 0.988）、精密度（日间相对标准偏差 = 1.05%，分析人员间相对标准偏差 = 1.02%）和准确度（101.23%，相对标准偏差 = 0.72%）。使用相同样品将生物测定法与高效液相色谱法（HPLC）进行了相关性分析，估计效价分别为100.90%和99.37%。结果表明，生物测定法是评估左氧氟沙星药物制剂效价和生物活性的合适方法。
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