Ranjane Poonam N, Gandhi Santosh V, Kadukar Sayali S, Bothara Kailash G
Department of Pharmaceutical Analysis, A.I.S.S.M.S. College of Pharmacy, Kennedy Road, Near R.T.O., Pune-411 001.
J Chromatogr Sci. 2010 Jan;48(1):26-8. doi: 10.1093/chromsci/48.1.26.
A new simple high-performance thin layer chromatographic method for determination of cefuroxime axetil and ornidazole in combined tablet dosage form is developed and validated. Cefuroxime axetil is second-generation cephalosporin used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Ornidazole is used to cure protozoan infections. The separation is carried out on Merck precoated silica gel aluminium plate 60 F(254) using toluene-n-butanol-triethylamine (8.5:2:0.5, v/v/v) as mobile phase. Quantitative determination of drugs is carried out by densitometric scanning of plates at 285 nm. The retention factor for ornidazole and cefuroxime axetil is found to be 0.51 +/- 0.007 and 0.67 +/- 0.009, respectively. The method is validated with respect to linearity, accuracy, precision, and robustness. Response found to be linear in the concentration range of 100-500 ng/band for both cefuroxime axetil and ornidazole. The method has been successfully applied for the analysis of drugs in pharmaceutical formulation. The % assay is found to be 102.36 +/- 0.775 and 101.00 +/- 1.192 for cefuroxime axetil and ornidazole, respectively.
开发并验证了一种用于测定复方片剂剂型中头孢呋辛酯和奥硝唑的新型简便高效薄层色谱法。头孢呋辛酯是第二代头孢菌素，用于治疗或预防已证实或高度怀疑由细菌引起的感染。奥硝唑用于治疗原生动物感染。采用甲苯 - 正丁醇 - 三乙胺（8.5:2:0.5，v/v/v）作为流动相，在默克预涂硅胶铝板60 F(254)上进行分离。通过在285 nm处对板进行光密度扫描来定量测定药物。发现奥硝唑和头孢呋辛酯的保留因子分别为0.51±0.007和0.67±0.009。该方法在线性、准确度、精密度和稳健性方面得到了验证。头孢呋辛酯和奥硝唑在100 - 500 ng/条带的浓度范围内响应呈线性。该方法已成功应用于药物制剂中药物的分析。头孢呋辛酯和奥硝唑的含量测定分别为102.36±0.775和101.00±1.192。
