Development and validation of a capillary electrophoresis method within a pharmaceutical quality control environment and comparison with high-performance liquid chromatography

1997 ◽  
Vol 773 (1-2) ◽  
pp. 339-350 ◽  
Author(s):  
G.S Wynia ◽  
G Windhorst ◽  
P.C Post ◽  
F.A Maris
Keyword(s):  
Quality Control ◽  
High Performance Liquid Chromatography ◽  
Capillary Electrophoresis ◽  
Liquid Chromatography ◽  
High Performance ◽  
Control Environment ◽  
Pharmaceutical Quality ◽  
Capillary Electrophoresis Method ◽  
Electrophoresis Method ◽  
Development And Validation

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

2020 ◽  
Vol 16 (5) ◽  
pp. 615-622
Author(s):  
Tian Luo ◽  
Shujuan He ◽  
Yueting Deng ◽  
Ximin Zhang ◽  
Yuming Dong
Keyword(s):  
High Performance Liquid Chromatography ◽  
Capillary Electrophoresis ◽  
Liquid Chromatography ◽  
High Performance ◽  
Direct Determination ◽  
Dissolution Profile ◽  
Alendronate Sodium ◽  
Capillary Electrophoresis Method ◽  
Electrophoresis Method

Background: Alendronate sodium is a common clinical osteoporosis drug for postmenopausal women; its determination is very important. However, there is no absorption of chromophores or fluorophores in the molecule, therefore, their direct determination is a challenge. Thus, establishing a common and direct method is very inspiring. Methods: 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, the 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 to be highly similar. Underivatized alendronate sodium can be determined by the capillary electrophoresis method. Results: Optimum conditions were as follows: background electrolyte including 25 mM CuSO4 at pH 4.59, 5 s injection time, 18 kV applied voltage, and 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 (0.01 μg/mL), limit of quantification (0.04 μg/mL) and recovery (90.6 %- 109.0 %). Conclusion: The proposed capillary electrophoresis method has been proved to be simpler, faster and more convenient to test dissolution profile of alendronate sodium tablet than that of high performance liquid chromatography.

scholarly journals DEVELOPMENT AND VALIDATION OF A HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) ANALYTICAL METHOD FOR DETERMINATION OF AMOXICILLIN IN CAPSULES

2016 ◽  
Vol 13 (26) ◽  
pp. 78-87
Author(s):  
Tiago Hickman IGLIN ◽  
Flávia Nathiely Silveira FACHEL ◽  
Amanda Gonçalves GUWZINSKI ◽  
Airton Monza da SILVEIRA ◽  
Filipe de Medeiros ALBANO ◽  
...  
Keyword(s):  
Quality Control ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Forced Degradation ◽  
Semisynthetic Penicillin ◽  
The Stability ◽  
Development And Validation

Amoxicillin, substance-related to semisynthetic penicillin, has been widely used to treat infections caused by various microorganisms, however reports of suitable methods for the quantitative determination and indicative of the stability of formulations containing this substance are rare. Due to lack of studies on the forced degradation of the substance and on the need to monitor the quality of this type of formulation was proposed and validated a method for the determination of amoxicillin content in capsules by high-performance liquid chromatography - HPLC for the quality control of amoxicillin capsules, allowing the provision of useful information about the characteristics of this type of formulation and its stability. The method was validated for parameters of linearity, specificity, accuracy, precision, and robustness

scholarly journals DEVELOPMENT AND VALIDATION OF RAPID REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF STIGMASTEROL AND β-SITOSTEROL IN EXTRACTS OF VARIOUS PARTS (LEAVES, STEMS, AND ROOTS) OF XANTHIUM STRUMARIUM LINN.

2016 ◽  
Vol 10 (1) ◽  
pp. 234
Author(s):  
Anjoo Kamboj ◽  
Manisha Bhatti ◽  
Pooja Atri
Keyword(s):  
Quality Control ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Xanthium Strumarium ◽  
Simultaneous Estimation ◽  
Reverse Phase ◽  
Chromatography Method ◽  
Liquid Chromatography Method ◽  
Development And Validation

ABSTRACTObjective: Xanthium strumarium is a cocklebur or burweed belonging to family Asteraceae and commonly found as a weed, is widely distributed inNorth America, Brazil, China, Malasia, and hotter part of India. The herb is traditionally used mostly in treating several ailments. The present studydeals with development and validation of a reliable reverse phase high-performance liquid chromatography (RP-HPLC) method for the simultaneousestimation of Stigmasterol and β-sitosterol in the various extracts of the plant.Methods: The proposed method utilizes a Qualisil Gold C18 column (250×4.6 mm), 5 µm particle size, under isocratic elution conditions with themixture of acetonitrile:ethanol:water (85:14:1 v/v/v) at 25° as a mobile phase. An effluent flow rate of 1 ml/minute and ultraviolet detection at202 nm was used for the analysis of Stigmasterol and β-sitosterol.Results: The described method was linear in the range of range of 100-500 µg/ml and 10-500 µg/ml for stigmasterol and β-sitosterol respectively,with excellent correlation coefficients. The precision, robustness, and ruggedness values were also within the prescribed limits (<2%). The recoveryvalues were within the range, which indicates that the accuracy of the analysis was good and that the interference of the matrix with the recovery ofphytosterols was low. The phytosterols were found to be stable in a stock solution for 24 hrs (percentage relative standard deviation was below 2%)and no interfering extra peaks were observed under controlled stress conditions.Conclusion: The proposed method is simple, specific, precise, accurate, and reproducible and thus can be used as appropriate method for routineanalysis of X. strumarium phytosterols in quality control laboratories.Keywords: Xanthium strumarium, Reverse phase high-performance liquid chromatography method, Precision, Phytosterols, Quality control.

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