Development and Validation of a Stability Indicating Method Using High Performance Liquid Chromatography for the Determination of Recombinant Human Bone Morphogenetic Protein-2 in a Biorelevant Release Media

2016 ◽  
Author(s):  
Deblina Biswas
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Bone Morphogenetic Protein 2 ◽  
Stability Indicating Method ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Development And Validation ◽  
Recombinant Human Bone

scholarly journals ANALYITCAL METHOD DEVELOPMENT AND VALIDATION OF A REVERSED-PHASE HIGHPERFORMANCE LIQUID CHROMATOGRAPHY FOR THE DETERMINATION OF MODAFINIL IN BULK AND PHARMACEUTICAL DOSAGE FORMS

2016 ◽  
Vol 9 (5) ◽  
pp. 177
Author(s):  
Bijithra Cholaraja ◽  
Shanmugasundaram P ◽  
Ragan G ◽  
Sankar Ask ◽  
Sumithra M
Keyword(s):  
Particle Size ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Rp Hplc ◽  
Development And Validation

ABSTRACTObjective: To development and validation of a reversed-phase high-performance liquid chromatography (RP-HPLC) for the determination of modafinilin bulk and pharmaceutical dosage forms.Methods: A simple, precise, rapid, and accurate RP-HPLC method was developed for the estimation of modafinil in bulk and pharmaceutical dosageforms. Xterra RP 18 (250 mm × 4.6 mm, 5 µ particle size) with a mobile phase consisting of methanol:water 70:30 V/V was used. The flow rate1.0 ml/min and the effluents were monitored at 260 nm. The retention time and recovery time was 12 minutes. The detector response was linear inthe concentration of 10-50 µg/ml. The respective linear regression equation being Y=452.1x+65237. The limit of detection and limit of quantificationwere 4.547 and 1.377 mcg, respectively. The method was validated by determining its accuracy, precision, and system suitability.Result: The objective of the present work is to develop simple, precise, and reliable HPLC method for the analysis of modafinil in bulk andpharmaceutical dosage forms. This is achieved using the most commonly employed Xterra RP 18 (250 mm × 4.6 mm, 5 μ particle size) columndetection at 260 nm. The present method was validated according to ICH guidelines.Conclusion: In this study, a simple, fast and reliable HPLC method was developed and validated for the determination of modafinil in pharmaceuticalformulations.Keywords: Modafinil, Reversed-phase high-performance liquid chromatography, Estimation, ICH guidelines, Tablets. 

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

Sign in / Sign up

Export Citation Format

Share Document