|
|
|
| The methodology study of related substances detection in compound anastrozole intravaginal ring |
| 1.National Research Institute for Family Planning，Beijing, 100081；2.Beijing Mumicipal Corps，Chinese Armed Police Forced, Beijin |
|
|
|
|
Abstract Objective: To establish High Performance Liquid Chromatography (HPLC) method for detecting related substances in compound anastrozole vaginal ring, and to study on methodology of the HPLC method. Methods：The compound anastrozole vaginal ring was synthesized by the way of injection molding, and the breaking test was conducted under strong acid, strong alkaline, high temperature, oxidant or strong illumination. The repeatability, stability, accuracy, and the limit of detection (LOD) of the ring were also detected by HPLC method with a column of Diamonsil C18(2) (250mm × 4.6mm, 5μm) and UV detection at 210 nm. The mobile phase consisted of acetonitrile water (42:58, v/v) at a flow rate of 1.0 ml/min. The sample size was 20 μl and column temperature was 35 ℃. Results：The result of specificity test showed that the main drug and the related impurities, degradation products were well separated. Blank excipient had no interference for determination. Anastrozole detection limit was 3 ng/ml. The RSD of the reproducibility was 1.6 % and the RSD of the stability was 1.8 %. Conclusion：The established method for detecting related substances in compound anastrozole vaginal ring has the characteristics of operative simplicity, strong specificity and good repeatability.
|
|
|
|
|
|
|
|
|
