Ramakrishna N V S, Vishwottam K N, Wishu S, Koteshwara M
Biopharmaceutical Research, Suven Life Sciences Ltd., Serene Chambers, Banjara Hills, Hyderabad 500034, India.
J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Aug 5;822(1-2):326-9. doi: 10.1016/j.jchromb.2005.06.011.
A sensitive and selective HPLC method with UV detection (290 nm) was developed and validated for quantitation of pantoprazole, proton-pump inhibitor, in human plasma. Following a single-step liquid-liquid extraction with methyl tert-butyl ether/diethyl ether (70/30, v/v), the analyte and internal standard (zonisamide) were separated using an isocratic mobile phase of 10mM phosphate buffer (pH 6.0)/acetonitrile (61/39, v/v) on reverse phase Waters symmetry C18 column. The lower limit of quantitation was 20 ng/mL, with a relative standard deviation of less than 4%. A linear range of 20-5000 ng/mL was established. This HPLC method was validated with between-batch and within-batch precision of 1.3-3.2% and 0.7-3.3%, respectively. The between-batch and within-batch bias was -0.5 to 8.2 % and -2.5 to 12.1%, respectively. This validated method is sensitive and repeatable enough to be used in pharmacokinetic studies.
建立了一种灵敏且具选择性的带紫外检测（290 nm）的高效液相色谱法，并对其进行验证，用于定量测定人血浆中的质子泵抑制剂泮托拉唑。采用甲基叔丁基醚/乙醚（70/30，v/v）进行单步液液萃取后，在反相沃特世Symmetry C18柱上，使用10 mM磷酸盐缓冲液（pH 6.0）/乙腈（61/39，v/v）的等度流动相分离分析物和内标（唑尼沙胺）。定量下限为20 ng/mL，相对标准偏差小于4%。建立了20 - 5000 ng/mL的线性范围。该高效液相色谱法的批间精密度和批内精密度分别验证为1.3 - 3.2%和0.7 - 3.3%。批间偏差和批内偏差分别为 -0.5%至8.2%和 -2.5%至12.1%。这种经过验证的方法灵敏且可重复，足以用于药代动力学研究。
