Stability-indicating HPLC method for simultaneous determination of pantoprazole and domperidone from their combination drug product
Stability-indicating HPLC method for simultaneous determination of pantoprazole and domperidone from their combination drug product
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DOI：
10.1365/s10337-007-0452-y
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发表时间：
2008-01-01
期刊：
影响因子：
1.7
通讯作者：
Kannappan, Valliappan
中科院分区：
文献类型：
--
作者：
Thanikachalam, Sivakumar;Rajappan, Manavalan;Kannappan, Valliappan
一个稳定性指示HPLC方法已经开发，并随后验证了商业片剂中多潘立酮和泮托拉唑的同时测定。所提出的HPLC方法使用Phenomenex（R）Gemini C-18柱（150 mm × 4.6 mm i.d.，5 μ m）和由甲醇-乙腈-20 mM磷酸氢二钾和磷酸缓冲液pH 7.0（20：33：47，v/v/v）组成的移动的相，流速为1.19 mL/min（-1）。在285 nm波长下，根据峰面积进行紫外检测，并在多潘立酮浓度范围为0.5-5.0 μ g mL（-1）和泮托拉唑浓度范围为1.0-10 μ g mL（-1）（两种药物的R（2）> 0.999）时，用线性校准曲线进行定量。对该方法的准确度、精密度、线性、检测限、定量限和耐用性进行了验证。将多潘立酮、泮托拉唑及其复方制剂暴露于酸、碱和中性水解、氧化、干热和光解强制降解条件下，并采用拟定方法分析强制降解样品。由于该方法能有效地将药物与其降解产物分离，因此可作为稳定性指示方法用于散装和商业产品中这些药物的不稳定性测定。
A stability-indicating HPLC method has been developed and subsequently validated for the simultaneous determination of domperidone and pantoprazole in commercial tablets. The proposed HPLC method utilizes Phenomenex (R) Gemini C-18 column (150 mm x 4.6 mm i.d., 5 mu m) and mobile phase consisting of methanol-acetonitrile-20 mM dipotassium hydrogen phosphate and phosphoric acid buffer pH 7.0 (20:33:47, v/v/v) at a flow rate of 1.19 mL min(-1). Quantitation was achieved with UV detection at 285 nm based on peak area with linear calibration curves at concentration ranges 0.5-5.0 mu g mL(-1) for domperidone and 1.0-10 mu g mL(-1) for pantoprazole (R (2) > 0.999 for both drugs). The method was validated in terms of accuracy, precision, linearity, limits of detection, limits of quantitation and robustness. This method has been successively applied to pharmaceutical formulation and no interference from the tablet excipients was found. Domperidone, pantoprazole and their combination drug product were exposed to acid, base and neutral hydrolysis, oxidation, dry heat and photolytic stress conditions and the stressed samples were analyzed by the proposed method. As the proposed method could effectively separate the drug from its degradation products, it can be employed as stability-indicating method for the determination of instability of these drugs in bulk and commercial products.