高效液相層析法檢測錠劑中Esomeprazole之開發及確效   全文下載

Development and Validation of High Performance Liquid Chromatographic Method for The Determination of Esomeprazole in Tablets

一種簡單、具選擇性以及準確性之高效液相層析法（HPLC）已被開發及確效，並應用於錠劑中esomeprazole magnesium trihydrate（es）之分析。以C18管柱層析，乙?/磷酸緩衝溶液為移動相（60:40，v/v，pH 7，流速1.0 ml/min），配合波長205 nm紫外光檢測器，樣品可獲得適當分離。lansoprazole作為本實驗之內標準品。於濃度100~1000 ng/ml範圍內，es之校正曲線為線性（r = 0.9992，n = 4）。同日與異日內精密度之Rsd值分別介於0.66~0.86%及0.84~1.11%。錠劑中es之平均回收率介於97.82~98.22%。es易遭受中性、酸性、鹼性水解以及氧化、乾熱處理、光降解之破壞。本方法可用於例行性品管分析。

A simple, selective and accurate high performance liquid chromatographic (HPLC) method was developed and validated for the analysis of esomeprazole magnesium trihydrate (ES) in tablets. Chromatographic separation was achieved isocratically on a C18 column utilizing a mobile phase of acetonitrile/phosphate buffer (60:40, v/v, pH 7) at a flow rate of 1.0 mL/min with UV detection at 205 nm. Lansoprazole was used as an internal standard (IS). The calibration curve of ES was linear in the range of 100~1000 ng/mL (r = 0.9992, n = 4). The RSD values for intra- and inter-day precision were 0.66~0.86% and 0.84~1.11%, respectively. The proposed method was successfully applied to the determination of ES in tablets. The mean recovery for ES from the tablets ranged between 97.82~98.22%. ES was subjected to neutral, acid and alkali hydrolysis as well as oxidation, dry heat treatment and photodegradation. Being simple, accurate and selective, the method can be used for routine quality control analysis.