Development of a high-performance thin-layer chromatographic method for the simultaneous determination of newly co-formulated antiviral drugs sofosbuvir and velpatasvir in their pure forms and tablet dosage form

2019 ◽  
Vol 32 (2) ◽  
pp. 141-147 ◽  
Author(s):  
Roshdy E. Saraya ◽  
Magda Elhenawee ◽  
Hanaa Saleh
INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (10) ◽  
pp. 13-17
Author(s):  
V. V Kunjir ◽  
◽  
S. B. Jadhav ◽  
A. J Purkar ◽  
P. D. Chaudhari

A high performance thin layer chromatographic method has been developed for the simultaneous determination of olmesartan medoximil and metoprolol succinate from tablet dosage form. The mobile phase consisting of water-methanol-ammonium sulphate (4.5:4.5:1.5 v/v/v) and wavelength of detection 233 nm was used. The developed method was validated as per ICH guidelines.


Author(s):  
B. V. SUMA ◽  
DEVESWARAN R. ◽  
PREMNATH SHENOY

ABSTRACT Objective: To develop a new simple, selective and precise high-performance thin layer chromatographic method for determination of Dapagliflozin (DAPA) in bulk and tablet dosage form Methods: The present study describes development and validation of High performance thin layer chromatographic method for DAPA. The chromatographic separation was carried out on Merck precoated silica gel aluminium plate 60 F254 using Chloroform: Methanol (9:1v/v) as mobile phase. Quantitative determination of drug was carried out by densitometric scanning of plates at 223 nm using Camag TLC Scanner. Results: The chromatographic condition shows compact band with the retention factor for dapaglifloxin as 0.21 ± 0.004. The method was validated as per ICH guidelines for linearity, accuracy, precision and robustness. Response was found to be linear in the concentration range of 400 ng/ band to 1200 ng/band with linear regression value of 0.9953 with respect to peak area and concentration value The LOD and LOQ was found to be 1.2083 ng/band and 3.6616ng/ band. The percentage assay was found to be 100±0.05. Conclusion: This method under statistical analysis proved a selective, repeatable and accurate analysis of the drug. This method can be used for quantitative analysis of dapaglifloxin in the bulk drug and in tablet.    


INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (12) ◽  
pp. 51-55
Author(s):  
S Kathirvel ◽  
◽  
K. Madhu Babu

Described in this manuscript is the first reported new, simple high performance thin layer chromatographic method for the determination of tapentadol hydrochloride in bulk and its tablet dosage form. The drug was separated on aluminum plates precoated with silica gel 60 F254 with butanol: water: glacial acetic acid in the ratio of 6:2:2 (v/v/v) as mobile phase. Quantitative analysis was performed by densitometric scanning at 254 nm. The method was validated for linearity, accuracy, precision and robustness. The calibration plot was linear over the range of 200-600 ng band -1 for tapentadol hydrochloride. The method was successfully applied to the analysis of drug in a pharmaceutical dosage form.


INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (06) ◽  
pp. 29-35
Author(s):  
T Raja ◽  
◽  
A. L Rao

A new simple high performance thin layer chromatographic method for simultaneous determination of rupatidine fumarate and montelukast sodium in bulk and tablet dosage form was investigated. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of acetone:methanol:toluene (2:3:5, V/V/V). Densitometric evaluation of the separated zones was performed at 286 nm and the method was validated. The Rf values and drug content of rupatidine fumarate and montelukast sodium were 0.57±0.02, 0.68±0.02 and 98.3%, 97.67% respectively. The calibration curves of peak area versus concentration, were linear from 50-300 ng per band for both rupatidine fumarate and montelukast sodium and the regression coefficient (r2 ) was greater than 0.99. The method was validated for linearity, accuracy, robustness and application for assay as per ICH guidelines. The study showed that the developed method was simple and accurate and would be suitable for the simultaneous determination of rupatidine fumarate and montelukast sodium in bulk and pharmaceutical formulations.


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