VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF LINEZOLID IN A PHARMACEUTICAL DOSAGE FORM

被引:17
|
作者
Mohapatra, Sharmistha [1 ]
Annapurna, M. Mathrusri [1 ]
Kumar, B. V. V. Ravi [1 ]
Anwar, Mohammed [2 ]
Warsi, Musarrat Husain [3 ]
Akhter, Sohail [3 ]
机构
[1] Roland Inst Pharmaceut Sci, Dept Pharmaceut Anal & Qual Assurance, Ganjam 760010, Orissa, India
[2] Hamdard Univ, Fac Pharm, Dept Qual Assurance, New Delhi, India
[3] Hamdard Univ, Nanomed Res Lab, New Delhi, India
关键词
Forced degradation; ICH; Linezolid; LOD; LOQ; RP-HPLC; PERFORMANCE LIQUID-CHROMATOGRAPHY; RESISTANT STAPHYLOCOCCUS-AUREUS; IN-VITRO ACTIVITY; TEICOPLANIN; IMPURITIES; VANCOMYCIN; ASSAY;
D O I
10.1080/10826076.2011.585548
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
A rapid high performance liquid chromatographic method was developed and validated for the determination and stability evaluation of linezolid in pharmaceutical dosage forms. Separation of linezolid was successfully achieved on a C-18 column utilizing water: methanol (50:50 v/v) at a flow rate of 1 mL/min and eluate was monitored at 254 nm, with a retention time of 5.117 minute. The method was validated and the response was found to be linear in the drug concentration range of 0.001 mg/mL to 3.4 mg/mL. The mean values +/- RSD of the slope and the correlation coefficient were found to be 51169 +/- 0.290 and 0.9999, respectively. The RSD values for intra-and inter-day precision were found to be 0.782 (<1.00%) and 0.610 (<0.90%), respectively. The forced degradation kinetic study of linezolid by using HCl (0.5 N), NaOH (0.02 M), H2O2 (6% v/v), thermal (80 +/- 2 degrees C), and UV radiation (365 nm) were observed to be very specific.
引用
收藏
页码:2185 / 2195
页数:11
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