HPLC Determination of Lansoprazole and Method Application for the Formulation Development of Enteric‐coated Lansoprazole Pellets |
| |
| Authors: | Tong‐Rong Tsai Thau‐Ming Cham Yu‐Tse Wu |
| |
| Affiliation: | 1. School of Pharmacy, Kaohsiung Medical University, Kaohsiung 807, Taiwan, R.O.C. Tel: 886‐7‐312‐1101 ext. 2254;2. Fax: 886‐7‐321‐0683 |
| |
| Abstract: | The aim of this study was to develop a validated HPLC method for the determination of lansoprazole in dissolution medium and pellets. For the formulation development, we investigated the role of 2‐hydroxypropyl‐β‐cyclodextrin (HPβCD) on the dissolution of enteric‐coated pellets of lansoprazole prepared by the solution layering technique using a fluid bed coater. Dissolution results demonstrated the coating using Acryl‐Eze protected the formulations from releasing lansoprazole in acid medium for the first 2 h, and the addition of HPβCD improved the dissolution performance by 189%, compared with the group without HPβCD. The DSC analysis displaced an absence of the endothermic peak for the lyophilized products lansoprazole and HPβCD, and FTIR analysis demonstrated the band broadening, shifting or disappearance compared to the spectra of the physical mixture, which indicated the formation of the inclusion complex between lansoprazole and HPβCD. This study has developed a validated HPLC method to measure lansoprazole in test media and pellets, which was applied successfully to the formula tion development of enteric‐coated pellets. |
| |
| Keywords: | Lansoprazole Enteric‐coated pellets Pharmaceutical analysis |
|
|
