Method development and validation of an HPLC assay for the detection of hopantenic acid in human plasma and its application to a pharmacokinetic study on volunteers

2011 ◽  
Vol 23 (3) ◽  
pp. 403-414
Author(s):  
O. N. Pozharitskaya ◽  
V. M. Kosman ◽  
M. V. Karlina ◽  
A. N. Shikov ◽  
V. G. Makarov ◽  
...  
Keyword(s):  
Human Plasma ◽  
Pharmacokinetic Study ◽  
Method Development ◽  
Hplc Assay ◽  
Method Development And Validation ◽  
Development And Validation

BIO ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULANEOUS ESTIMATION OF NITAZOXANIDE AND OFLOXACIN IN HUMAN PLASMA BY RP-HPLC

INDIAN DRUGS ◽  
2021 ◽  
Vol 57 (10) ◽  
pp. 47-57
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Method Development ◽  
Reversed Phase ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Liquid Chromatography Method ◽  
Development And Validation ◽  
Lower Limits

An isocratic Reversed-Phase High Performance Liquid Chromatography method has been developed for rapid and simultaneous separation and estimation of two antibiotics, namely, nitazoxanide and ofloxacin, in human plasma. Separation was carried out on Altima C8 (150 x 4.6 mm, 5µ) column using a mobile phase of 0.1% ortho phosphoric acid: acetonitrile (50:50, V/V) at 260 nm. The retention time of nitazoxanide and ofloxacin was noted to be 4.850 and 7.949 min, respectively. The average % recovery for nitazoxanide and ofloxacin were 98.012 % and 94.176 %, respectively and reproducibility was found to be satisfactory. The linearity was investigated in the concentration range of 0.02-2 µg/ml (r2=0.9996) for nitazoxanide and 0.008-0.8 µg/ml (r2=0.9998) for ofloxacin. The lower limits of quantification were 0.0196 µg/ml and 0.0079 µg/ml for nitazoxanide and ofloxacin, respectively, which reach the level of both drugs possibly found in human plasma. The proposed method can be applied for etermination of nitazoxanide and ofloxacin from dosage forms during pharmacokinetic study.

Bioanalytical Method Development and Validation of Doravirine, Lamavudine and Tenofovir Disoproxil Fumarate using HPLC in Human Plasma

2021 ◽  
pp. 4087-4091
Author(s):  
Marakatham S. ◽  
Shanmugapandiyan P.
Keyword(s):  
Human Plasma ◽  
Tenofovir Disoproxil Fumarate ◽  
Method Development ◽  
Potassium Dihydrogen Phosphate ◽  
Internal Standard ◽  
Stability Study ◽  
Dihydrogen Phosphate ◽  
Bioanalytical Method ◽  
Method Development And Validation ◽  
Development And Validation

A novel, simple and sensitive bioanalytical method was developed for estimation of Doravirine, Lamavudine and tenofovir disoproxil fumarate in human plasma with daclatasvir as internal standard. The method was developed using alliance HPLC using Phenomenex C18 (150mm x 4.6mm, 5m) column with mobile phase of 0.01N Potassium dihydrogen phosphate pH (3.5): Acetonitrile (60:40) at flow rate of 1.0ml/min. Detection wavelength was found to be 277nm. The linearity range for doravirine, lamuvidine and Tenfovir was 50-2000ng/ml, 125-5000ng/ml and 20-800ng/ml. Correlation coefficient was 0.999. The method was validated and stability study was carried out as per FDA guidelines.

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