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.

SENSITIVE BIO ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF VENETOCLAX IN HUMAN PLASMA BY LC-ESI-MS/MS

INDIAN DRUGS ◽  
2020 ◽  
Vol 57 (06) ◽  
pp. 32-38
Author(s):  
H. Potluri ◽  
Keyword(s):  
Human Plasma ◽  
Method Development ◽  
Multiple Reaction Monitoring ◽  
Internal Standard ◽  
Liquid Liquid Extraction ◽  
Liquid Chromatography Tandem Mass ◽  
Positive Mode ◽  
Method Development And Validation ◽  
Development And Validation

A specific and sensitive method of liquid chromatography–tandem mass spectrometry was demonstrated for the experimental determination of venetoclax in human plasma utilising venetoclax-D8 as an internal standard. The column Xbridge C18, 50 × 4.6mm, 5 µm was used for attaining chromatographic separation by utilising 10mM ammonium formate and methanol as isocratic mobile phase in the composition ratio of 20:80 (V/V). The flow-rate selected was 0.7ml/min. Venetoclax and venetoclax-D8 are identified in multiple reaction monitoring (MRM) positive mode with proton adducts at m/z 869.53 →553.21 and m/z 877.14 → 553.23, respectively. For the successful extraction of drug as well as internal standard, liquid-liquid extraction technique was efficiently utilised. The developed technique was established in a linear concentration range of 5.0-5000.0 pg/ml along with correlation coefficient (r2) of 0.9994. Intra and inter-day precisions were found to be 0.7 to 1.90% and 0.7 to 2.0 % for venetoclax and venetoclax-D8, respectively. Accuracy was found to be within 98.6 to 101.99% and 99.17 to 101.14 % for venetoclax and venetoclax-D8, respectively. It was observed that throughout the bench top studies, post-operative stability studies and freeze-thawing cycles, venetoclax retained stability.

scholarly journals Analytical method development and validation for simultaneous estimation of Fimasartan Potassium Trihydrate and Cilnidipine in synthetic mixture by HPLC for the treatment of hypertension stage-II

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Radhika G. Sojitra ◽  
Urvi J. Chotaliya
Keyword(s):  
Method Development ◽  
Potassium Dihydrogen Phosphate ◽  
Cost Effective ◽  
Hplc Method ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Method Development And Validation ◽  
Dose Combination ◽  
Development And Validation

Abstract Background A specific, accurate, precise, robust, and cost-effective HPLC method was developed and validated for quantitative analysis of Fimasartan Potassium Trihydrate and Cilnidipine in fixed-dose combination. The isocratic elution was accomplished by Symmetry C18 column (150 mm × 4.6 mm, 5 µm) at 25 °C. Mobile phase composition is Methanol: Acetonitrile: Potassium Dihydrogen Phosphate buffer (pH 3) (60:05:35%v/v/v) at a flow rate of 1.0 mL/min, injection volume 20 µL with DAD detection at 240 nm. Result Fimasartan Potassium Trihydrate and Cilnidipine were eluted with retention time 2.65 min and 5.51 min respectively. This method was validated as per ICH guideline (Q2 R1). The calibration plots were over the concentration range of 15–90 μg/mL and 2.5–15 μg/mL for Fimasartan Potassium Trihydrate and Cilnidipine with correlation coefficient 0.9992 and 0.9989 respectively. Accuracy was obtained between 99.51–101.65% and 100.06–101.20% for Fimasartan Potassium Trihydrate and Cilnidipine respectively. LOD were found to be 0.97 μg/mL and 0.57 μg/mL and LOQ were found to be 2.95 μg/mL and 1.75 μg/mL for Fimasartan Potassium Trihydrate and Cilnidipine respectively. Conclusion The results showed that the developed method is reliable for the routine analysis for simultaneous determination of Fimasartan Potassium Trihydrate and Cilnidipine.

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