Analysis of Fludrocortisone Acetate and Its Solid Dosage Forms by High-Performance Liquid Chromatography

1979 ◽  
Vol 68 (4) ◽  
pp. 421-423 ◽  
Author(s):  
Therese M. Ast ◽  
Hamed M. Abdou
2018 ◽  
Vol 2 (1) ◽  
pp. 13-20 ◽  
Author(s):  
Irene C K Guerreiro ◽  
Samuel Davies ◽  
Silvia Guterres ◽  
Simone Jacobus Berlitz

A high-performance liquid chromatography-ultraviolet (HPLC-UV) method was developed and validated for simultaneous determination of Resveratrol (RSV) and Lipoic Acid (LA). A C18 column was used with a mobile phase consisting of acetonitrile and 0.01M phosphoric acid (60:40). The detection wavelength was at 235 nm. The method was specific in the presence of pharmaceutical excipients widely used in solid dosage forms or lipid-core nanocapsules. The results demonstrated linearity between 5 and 50 µg/mL for RSV and 30 and 120 µg/mL for LA. The method presented precision and accuracy (RSD <5%). In addition, the developed method was considered robust. Therefore, the developed method can be applied successfully for simultaneous determination of RSV and LA in the proposed conditions, with a potential application to assay both drugs in several dosage forms.


Author(s):  
Mannem Durga Babu ◽  
Kesana Surendrababu

Objective: The objective of the study was to develop and validate a novel, specific, precise, and simple reversed-phase high-performance liquid chromatography method for the estimation of guaifenesin present in methocarbamol API and its pharmaceutical dosage forms. Methods: The baseline separation for methocarbamol and guaifenesin was achieved by utilizing a Inertsil ODS C18 (250 mm × 4.6 mm) 5 μm column particle size and an isocratic elution method. The mobile phase contains a mixture of water and acetonitrile in the ratio of 70:30 v/v, respectively. The flow rate of the mobile phase was 1.0 mL/min with a column temperature of 25°C and detection wavelength at 272 nm. The method was validated for a limit of detection (LOD), limit of quantification (LOQ), linearity, accuracy, and reproducibility with the help of the exhibit and simulated samples. Results: The LOD for guaifenesin was 0.62 μg/mL. The LOQ for guaifenesin was 1.87 μg/mL. The correlation coefficient obtained for impurity was >0.99. The recovery was obtained for impurity was 106.56% at 50%, 95.20% at 100%, and 100.45% at 150%. In tablet analysis, we can found 0.26% (<0.5%). Conclusion: The developed method was validated as per the ICH guidelines with respect to specificity, precision, linearity, accuracy, LOD and quantification, ruggedness, robustness, and solution stability.


Author(s):  
Bijithra Cholaraja ◽  
Shanmugasundaram P ◽  
Ragan G ◽  
Sankar Ask ◽  
Sumithra M

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. 


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