Submit Manuscript  

Article Details


Establishing Tablet Dissolution Curve Through Determination of Underivatized Alendronate Sodium by Capillary Electrophoresis-UV Detector

Author(s):

Tian Luo, Shujuan He, Yueting Deng, Ximin Zhang and Yuming Dong*   Pages 1 - 7 ( 7 )

Abstract:


Background Alendronate sodium as a common clinical osteoporosis drug for postmenopausal women, it’s determination is very important. However there are no absorption chromophores or fluorophores in the molecule, their direct determination is a challenge. Thus, establishing a common and direct method is very inspire.

Method: According to the direct determination of alendronate sodium through the formation of a complex between alendronate sodium and divalent copper ion by capillary electrophoresis with ultraviolet detection, dissolution profile of alendronate sodium tablet was established. The dissolution curves obtained from high performance liquid chromatography method involving derivatization with 9-fluorenyl methylchloroformate and capillary electrophoresis with ultraviolet detector were found highly similar. Underivatized alendronate sodium can be determined by capillary electrophoresis method.

Results: Optimum conditions were as follows:

Background electrolyte including 25 mM CuSO4 at pH to 4.59, 5s injection time, 18 kV applied voltage, 240 nm detected wavelength. Method validation indicated good linearity (r2>0.9993), precision of migration time with a relative standard deviation <1.5% for intra-day and <3.6% for inter-day, precision of peak areas <2.3% for intra-day and <5.0% for inter-day, limits of detection (0.01µg/mL), limit of quantification (0.04µg/mL) and recovery (90.6%-109.0%).

Conclusion: The proposed capillary electrophoresis method was simpler, faster and more conveniently to test dissolution profile of alendronate sodium tablet than that of high performance liquid chromatography.

Keywords:

Pharmaceutical analysis, Capillary electrophoresis, Assay, Alendronate sodium, Dissolution curve, Direct determination

Affiliation:

Institute of Pharmaceutical Analysis, School of Pharmacy, Lanzhou University, Lanzhou, Gansu Province 730000, P. R., Institute of Pharmaceutical Analysis, School of Pharmacy, Lanzhou University, Lanzhou, Gansu Province 730000, P. R., Key Laboratory of Traditional Chinese Medicine Solid Dispersion Preparation, Gansu longshenrongfa Pharmaceutical Industry Co., Ltd, Gansu Province, 73000, P. R., Key Laboratory of Traditional Chinese Medicine Solid Dispersion Preparation, Gansu longshenrongfa Pharmaceutical Industry Co., Ltd, Gansu Province, 73000, P. R., Institute of Pharmaceutical Analysis, School of Pharmacy, Lanzhou University, Lanzhou, Gansu Province 730000, P. R.



Read Full-Text article