Validated, Ultra High Efficiency RP-HPLC and Stability Indicating Method for Determination of Tranylcypromines Sulphate in Bulk and in Tablet Dosage Forms

نویسندگان

  • Gamal H. Ragab
  • Hanaa M. Saleh
  • Magda M. EL-Henawee
  • Omnia F. Elsayed
چکیده

Article history: Received on: 18/11/2015 Revised on: 16/12/2015 Accepted on: 07/01/2016 Available online: 27/02/2016 Simple, sensitive, rapid and stability indicating ultra high efficiency RP-HPLC method was developed and validated for analysis of Tranylcypromine sulphate in bulk drug and in tablet dosage forms. Wellresolved peaks of target analyte and its degradation products were achieved on a Kinetex ® column (75 mm x 4.6 mm ID) 2.6 μm at 30 ° C, using simple isocratic mobile phase of acetonitrile orthophosphoric acid 0.1 % (10: 90, v/v). The flow rate was 1.0 mL/min and the detection was performed at 220 nm. The retention time of the drug was 2 min while for the reported method was 6.7 min. The method was validated according to International Conference on Harmonization (ICH) guidelines. Tranylcypromine was subjected to the stress conditions of hydrolytic acidic, basic, oxidative, and photolytic degradation. The assay was linear over the concentration range of 3-150 μg mL -1

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تاریخ انتشار 2016