Part~I: Solution conformation of peptides and polypeptides using particle beam LC/FT-IR spectrometry and electrospray mass spectrometry. Part~II: HPLC methods development for selected pharmaceutical mixtures in 0.9 percent sodium chloride injection USP.

摘要

HPLC methods for the analysis of Angiotensin I (Ang I), POMC-X, ;Studies with Ang I and POMC-X indicated that they do not behave similarly under identical conditions. It was observed that both Ang I and POMC-X had slightly different conformations in the various parenteral solutions. The conformation of Ang I changed with both pH and temperature while POMC-X was stable to both temperature and pH changes. The identity of the peptides and the conformationally sensitive charge-state intensities of the peptides were investigated with Electrospray ionization (ESI/MS) mass spectrometry. The combination of the infrared and mass spectrometric data allowed a thorough estimation of the solution effects on the conformation of the model peptides.;;Chapters 3-7 are reports of HPLC methods developed for selected pharmaceutical mixtures in 0.9% Sodium Chloride injection USP. The separation of quantitation of the drug mixtures under various conditions have been described. The methods developed have been validated. Linearity, accuracy and precision, reproducibility (inter and intra day), limit of detection and limit of quantitation were determined as part of validation. The validated methods were used for the stability studies of the drug mixtures over a period of 24 hours.