scholarly journals A Validated Reverse Phase HPLC Technique for the Determination of TATB Assay

2016 ◽  
Vol 13 (3) ◽  
pp. 641-657 ◽  
Author(s):  
Sibes Bhattacharyya ◽  
Rajendra Patil ◽  
Mada Santosh ◽  
Bikash Bhattacharya ◽  
Ranjan Malik ◽  
...  
2006 ◽  
Vol 3 (1) ◽  
pp. 60-64 ◽  
Author(s):  
P. Venkata Reddy ◽  
B. Sudha Rani ◽  
G. Srinu Babu ◽  
J. V. L. N. Seshagiri Rao

A reverse phase HPLC method is developed for the determination of Raloxifene in pharmaceutical dosage forms. Chromatography was carried out on an inertsil C18 column using a mixture of acetonitrile and phosphate buffer (30:70 v/v) as the mobile phase at a flow rate of 1 mL/min. Detection was carried out at 290 nm .The retention time of the drug was 10.609 min. The method produced linear responses in the concentration range of 0.5-200 µg/mL of Raloxifene. The method was found to be applicable for determination of the drug in tablets.


1972 ◽  
Vol 6 (2) ◽  
pp. 2253-2262
Author(s):  
M. López-Rivadulla ◽  
P. Fernández ◽  
P. Rodríguez ◽  
A. M. Bermejo ◽  
L. Concheiro

Author(s):  
Devi Ramesh ◽  
Mohammad Habibuddin

Objective: The objective of the present study is to develop and validate a simple, rapid, sensitive reverse phase HPLC method for the determination of Armodafinil present in bulk and its pharmaceutical formulations.Methods: The chromatographic separation was achieved by using Hypersil ODS C-18 (150 x 4.6 mm, 5µ) in an isocratic mode with mobile phase methanol: phosphate buffer 3.0 (60:40 %v/v) was used. The flow rate was 1 ml/min and effluent was monitored at 225 nm. The method was validated for validation parameters i.e. linearity, accuracy, precision and robustness according to ICH guidelines.Results: The retention time of Armodafinil was 4.2 min and the linearity range of the method was 500-20000ng/ml with regression (r2) coefficient 0.9998. The method was validated for precision, accuracy, robustness and which were found to be within the acceptable limits according to the ICH guidelines. Also, the method was successfully applied for the estimation of Armodafinil in the marketed formulation of Nuvigil and the recovery was found to be>98%.Conclusion: The developed method possess good selectivity, specificity, there is no interference found in the blank at a retention time of ARM and good correlation between the peak area and concentration of the drugs under prescribed conditions. Hence, the method can be applied for routine analysis of Armodafinil. 


2010 ◽  
Vol 7 (2) ◽  
pp. 501-513 ◽  
Author(s):  
A. K. Chaudhary ◽  
S. Ankushrao Waske ◽  
S. Yadav ◽  
T. G. Chandrashekhar ◽  
Vandana Singh

A simple, rapid, accurate and economic reverse phase HPLC method was developed and validated for determination of di-(2-ethylhexyl)phthalate (DEHP) in reconstituting diluents and reconstituted solutions of imipenem and cilastatin for injection The method was applied to detect any leaching enhancement in presence of imipenem and cilastatin in reconstituted injections. Imipenem and cilastatin for injection is a widely used broad spectrum beta-lactam antibiotic. As per requirements of various regulatory authorities of different countries, DEHP content needs to be monitored in the reconstituting diluents used to reconstitute injections. The proposed method is a unique method wherein DEHP can be determined directly without any sample pre-treatment before analysis. The method can be used as a good quality control tool to control the leaching of DEHP in the reconstituting diluents and reconstituted injections. The method utilizes C18column (250 × 4.6 mm, 5μ) and a mixture of methanol, propan-2-ol and water as mobile phase. DEHP was detected at 225 nm. The method has low limit of quantification (0.058 μg mL-1) which is much below the acceptance limit calculated as per USFDA tolerance criteria (3.5 μg mL-1for adults and 0.3 μg mL-1for neonates and infants).


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