Pawar Shubhangi M, Khatal Laxman D, Gabhe Satish Y, Dhaneshwar Sunil R
Research and Development Centre in Pharmaceutical Sciences and Applied Chemistry, Poona College of Pharmacy, Bharati Vidyapeeth University, Pune, Maharashtra 411038, India.
Bioanalytical Research Department, BioAnalytical Technologies Pvt. Ltd., Pune, Maharashtra 411030, India.
J Pharm Anal. 2012 Aug;2(4):264-271. doi: 10.1016/j.jpha.2012.02.009. Epub 2012 Mar 15.
The objective of current study was to develop a validated specific stability indicating reversed-phase liquid chromatographic method for the quantitative determination of desvenlafaxine in bulk sample and pharmaceutical dosage form in the presence of degradation products. Forced degradation studies were performed on bulk sample of desvenlafaxine as per ICH prescribed stress conditions using acid, base, oxidative and photolytic degradation to show the stability indicating power of the method. Significant degradation was observed under acidic stress condition and the degradation product formed was identified by LC-MS and a degradation pathway for drug has been proposed. Successful separation of drug from degradation products formed under stress conditions was achieved on a SymmetryShield column C (5 μm, 250 mm×4.6 mm, i.d.) using the mobile phase consisting of a mixture of 0.2% (v/v) triethylamine in ammonium acetate (0.05 M; pH 6.5) and methanol using isocratic gradient.
本研究的目的是开发一种经过验证的特定稳定性指示反相液相色谱法，用于在有降解产物存在的情况下定量测定原料药和药物剂型中的去甲文拉法辛。按照ICH规定的加速试验条件，对去甲文拉法辛原料药进行强制降解研究，采用酸、碱、氧化和光解降解，以证明该方法的稳定性指示能力。在酸性应激条件下观察到显著降解，并通过LC-MS鉴定了形成的降解产物，并提出了药物的降解途径。使用由0.2%（v/v）三乙胺在醋酸铵（0.05M；pH6.5）和甲醇的混合物组成的流动相，采用等度梯度，在SymmetryShield柱C（5μm，250mm×4.6mm，内径）上成功地将药物与应激条件下形成的降解产物分离。
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