Development and Validation of Reverse Phase HPLC Method for Enantiomer Excess Determination of Tenofovir Disoproxil Fumarate drug Substance

2020 ◽  
Vol 13 (5) ◽  
pp. 334-340
Author(s):  
Ch. Ramesh ◽  
D. Rama Devi ◽  
MNB. Srinivas ◽  
Nagaraju Rajana ◽  
S. Radha Krishna ◽  
...  
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
Hplc Method ◽  
Drug Substance ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Enantiomer Excess ◽  
Development And Validation

scholarly journals Development and Validation of RP-Chiral HPLC Method for Determination of (R)-Enantiomer Excess Content in Efavirenz

2020 ◽  
Vol 32 (9) ◽  
pp. 2208-2212
Author(s):  
CH. RAMESH ◽  
DHARMASOTH RAMA DEVI DEVI ◽  
M.N.B. SRINIVAS ◽  
S. RADHA KRISHNA ◽  
NAGARAJU RAJANA ◽  
...  
Keyword(s):  
Limit Of Detection ◽  
Hplc Method ◽  
Chiral Hplc ◽  
Reverse Phase ◽  
Limit Of Quantification ◽  
Column Temperature ◽  
Enantiomer Excess ◽  
Development And Validation ◽  
Methyl Phenyl

simple, specific, linear, accurate and precise reverse phase chiral HPLC method was developed for the separation of efavirenz enantiomers by using the Lux Amylose-2 column containing amylose tris(5-chloro-2-methyl phenyl carbamate) as a stationary phase. The mobile phase consists of 0.1 % formic acid in water and acetonitrile (55:45, v/v). The flow rate was kept at 1.0 mL/min and the detection wavelength used 252 nm and the column temperature was set at 25 ºC. The limit of detection was 0.01 mg/mL and the limit of quantification was 0.04 mg/mL. The linearity calibration curve of (R)-enantiomer was shown well from the range of 0.04 mg/mL to 0.4 mg/mL. The values of the correlation coefficient were 0.999 and 0.999 for (R)-enantiomer and (S)-efavirenz, respectively. The percentage recoveries of (R)-enantiomer from efavirenz drug substance were ranged from 93.5% to 107.5%. The results demonstrated that developed RP-chiral HPLC method was simple, precise, robust and applicable for the estimation of (R)-enantiomer in efavirenz API. This method was validated in as per ICH Q2 (R1) and USP validation of compendial methods <1225>.

scholarly journals Validation of Stability-Indicating Reverse Phase HPLC Method for the Determination of Related Substances in Dapagliflozin Drug Substance

2018 ◽  
Vol 8 (5) ◽  
pp. 322-336
Author(s):  
Goutam Sen ◽  
K. Raghu Babu ◽  
N. Annapurna ◽  
N.A. Vekariya ◽  
Vundavilli Jagadeesh Kumar ◽  
...  
Keyword(s):  
Hplc Method ◽  
Drug Substance ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Stability Indicating ◽  
Related Substances
Sign in / Sign up

Export Citation Format

Share Document