HPLC Determination of the content of duloxetine hydrochloride and related substances.docVIP

 PAGE \* MERGEFORMAT 14 HPLC Determination of the content of duloxetine hydrochloride and related substances Keywords: high-performance liquid chromatography; Duloxetine hydrochloride; content; related substances [Abstract] Objective: To establish a HPLC determination of duloxetine hydrochloride content and related substances. Methods: ODS2C18 (4.6 mm × 250 mm, 5 μm) column, mobile phase 0.025 mol / L potassium dihydrogen phosphate solution acetonitrile-methanol (3:2:2), flow rate 1.0 mL / min, detection wavelength of 290 nm. Results: 9.0 ~ 45.0 μg / mL within the chromatographic peak area and concentration showed a good linear relationship, r = 0.9999; recovery was 100.2% (RSD = 0.75%, n = 9), the minimum detection limit of 4 ng / mL. Conclusion: The method is accurate, simple, sensitive and can be used for determination of duloxetine hydrochloride and related substances. [Keywords:] high-performance liquid chromatography; Duloxetine hydrochloride; content; related substances Determination of contents of duloxetine hydrochloride and its related substances with HPLC ZHUO Zhi1, WANG Qing2 (1.Chongqing Institute For Drug Control, Chongqing 401121, China; 2. Chongqing Shenghuaxi Pharmaceupical CO. LTD, Chongqing 400061, China) [Abstract] Objective: To establish an HPLC method to detemine duloxetine hydrochloride and its related substances. Methods: A Diamonsil ODS2C18 column (4.6 mm × 250 mm, 5 μm) was used with the mobile phase of 0.025 mol / L potassium dihydrogen phosphateacetonitrilemethol ( 3:2:2) at the detection wavelength of 290 nm. The flow rate was 1.0 mL / min. Results: The calibration curve was linear in the range of 9.0 ~ 45.0 μg / mL, r = 0.9999. The average recovery was 100.2 % (RSD = 0.75%, n = 9). The minimum detection amount of duloxetine hydrochloride was 4 ng. Conclusions: This method is accurate, simple and sensitive, and it can be used for the assay or related substances control of duloxetine hydrochl