A Validated Reverse-Phase HPLC Method for Quantitative Determination of Ganoderic Acids A and B in Cultivated Strains of Ganoderma spp. (Agaricomycetes) Indigenous to India

2017 ◽  
Vol 19 (5) ◽  
pp. 457-465 ◽  
Author(s):  
M. Ramakrishna ◽  
D. Rajesh Babu ◽  
S. S. Veena ◽  
Meera Pandey ◽  
Nageswara Rao
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.


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).


2011 ◽  
Vol 8 (s1) ◽  
pp. S119-S126
Author(s):  
S. Venugopal ◽  
U. M. Tripathi ◽  
N. Devanna

This paper describes the development of reverse phase HPLC method for etoricoxib in the presence of impurities and degradation products generated from the forced degradation studies. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation of etoricoxib was observed under base and oxidation environment. The drug was found stable in other stress conditions studied. Successful separation of the drug from the process related impurities and degradation products were achieved on zorbax SB CN (250 x 4.6 mm) 5 μm particle size column using reverse phase HPLC method. The isocratic method employed with a mixture of buffer and acetonitrile in a ratio of 60:40 respectively. Disodium hydrogen orthophosphate (0.02 M) is used as buffer and pH adjusted to 7.20 with 1 N sodium hydroxide solution. The HPLC method was developed and validated with respect to linearity, accuracy, precision, specificity and ruggedness.


2009 ◽  
Vol 6 (4) ◽  
pp. 1188-1192 ◽  
Author(s):  
G. Rathinavel ◽  
U. Uma Nath ◽  
J. Valarmathy ◽  
L. Samueljoshua ◽  
C. Selvin Thanuja ◽  
...  

A reverse phase HPLC method is described for the determination of rosiglitazone and gliclazide in tablet dosage form. Chromatography was carried on Phenomenix Gemini C18column using in mixture of ammonium phosphate buffer, Acetonitrile and methanol in the ratio 50: 35: 15 v/v as mobile phase at a flow rate 1 mL min-1and the effluent was monitored at 254 nm. The retention time for rosiglitazone was 3.74 and gliclazide 7.84 min. The limit of detection for rosiglitazone was 4.07μg/mL and gliclazide 1.19 μg/mL. The LOQ obtained for rosiglitazone was 12.33 μg/mL and 3.612 μg/mL. The percentage assay for rosiglitazone was 99.92% and gliclazide was 99.82%. The method was validated for accuracy precision and system suitability. The proposed method was fast accurate and precise so it can be used for regular quality control of the drug.


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