Abstract
Objectives of present investigation were to develop novel high throughput green UPLC-MS/MS methods for quality control of desmopressin formulations. Two liquid chromatographic methods: Method-I based on isocratic elution and method-II based on gradient elution were developed and validated. Methods were green, since less amount of organic solvent (<= 75 mu L, per sample run time) was utilized in mobile phase. Mobile phase (0.1% formic acid in ACN, and in water), flow rate was 300 mu L/min. Desmopressin retention time and sample run time for Method-I were 0.59 and 1.0 min, respectively. Retention time and sample run time for method-II were 2.03 and 2.5 min, respectively. Double charged ions [M + 2H](2+) of desmopressin (m/z 535.33 > 120) were monitored in multi-reaction monitoring mode. Desmopressin was directly analyzed in water samples. Calibration curves were prepared between 50 and 600 ng/mL. The values of r(2) were 0.999. Assay and dissolution study of desmopressin formulation was successfully performed using these methods. Desmopressin was found to adsorb or react with different type of materials while handling. The specific filters (Chromafil (R) Xtra PTFE-45/25 0.45 mu m, syringe filter) and tubes (glass tubes or Neutral graduated micro test tubes) were used for handling desmopressin samples.