scholarly journals RP-HPLC Method Development and Its Validation for Quantitative Determination of Rimonabant in Human Plasma

2012 ◽  
Vol 2012 ◽  
pp. 1-4 ◽  
Author(s):  
Shravan Bankey ◽  
Ganesh Tapadiya ◽  
Jasvant Lamale ◽  
Deepti Jain ◽  
Shweta Saboo ◽  
...  
Keyword(s):  
Human Plasma ◽  
Mobile Phase ◽  
Method Development ◽  
Bioequivalence Study ◽  
Hplc Method ◽  
Liquid Extraction ◽  
Liquid Liquid Extraction ◽  
Rp Hplc ◽  
Hplc Method Development

A simple, accurate, and precise HPLC method was developed and validated for determination of rimonabant in human plasma. Following liquid-liquid extraction, chromatographic separation was accomplished using C18 column with mobile phase consisting of acetonitrile : water (90 : 10, v/v), drug was detected at 260 nm using UVdetector. The LOD and LOQ were 3.0 and 10.0 μg/L, respectively. The method is linear in the interval 50.0–1000.0 μg/L. The average extraction recovery of drug from plasma was found to be 92.2%. The percent CV of the method was found to be less than 10.8%, and accuracy was found between 94.5 and 106.7%. The assay may be applied to a pharmacokinetic and bioequivalence study of rimonabant.

A NEW BIOANALYTICAL METHOD DEVELOPMENT & VALIDATION FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE MONOHYDRATE IN HUMAN PLASMA BY USING RP-HPLC

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (12) ◽  
pp. 18-25
Author(s):  
S. A Kumar ◽  
◽  
M Debnath ◽  
J. V. L. N. S Rao ◽  
G Sankar
Keyword(s):  
Human Plasma ◽  
Mobile Phase ◽  
Method Development ◽  
Hplc Method ◽  
Precipitation Method ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Dihydrogen Phosphate ◽  
Rp Hplc

A new RP-HPLC method for the quantitative determination of metformin and sitagliptin in human plasma was developed and validated as per US-FDA guidelines. The drug was spiked in the plasma and extracted with mobile phase by precipitation method. The extracted analyte was injected into Symmetry C18 (4.6 x 150 mm, 3.5μm, Make: XTerra) or equivalent, maintained at ambient temperature and effluent was monitored at 254 nm. The mobile phase consisting of potassium dihydrogen phosphate [pH 5.8]: acetonitrile [HPLC Grade] (65:35 v/v). The flow rate was maintained at 0.9 mL/min. The calibration curve for metformin and sitagliptin was linear from 10.0 to 35.0 µg/mL (r2= 0.999) and 1.0 to 3.5 µg/mL (r2= 0.998) respectively. The inter-day and intra-day precision was found to be within limits. The lower limit of quantification (LLOQ) for metformin and sitagliptin were found to be 0.026 and 0.70 μg/mL respectively. The average % recovery for metformin and sitagliptin were found to be 98.82-100.03 & 99.76-100.89 % respectively and reproducibility was found to be satisfactory. This RP-HPLC method is suiTable for determining the concentration of metformin and sitagliptin in human plasma and it can applied for routine analysis for determination of the metformin and sitagliptin from dosage form during pharmacokinetic study.

RP-HPLC method development for simultaneous determination of the drugs Ramipril and Amlodipine

2012 ◽  
Vol 2 (2) ◽  
pp. 364-367 ◽  
Author(s):  
Saida Naik Dheeravath ◽  
◽  
Kasani Ramadevi ◽  
Zilla Saraswathi ◽  
Dheeravath Maniklal ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Method Development ◽  
Hplc Method ◽  
Rp Hplc ◽  
Hplc Method Development

RP-HPLC METHOD DEVELOPMENT FOR THE ASSAY OF AMPHOTERICIN B

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (02) ◽  
pp. 16-20
Author(s):  
L Mohankrishna ◽  
◽  
P. J. Reddy ◽  
B. P Reddy. ◽  
P. Navya
Keyword(s):  
Amphotericin B ◽  
Mobile Phase ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Phase Combination ◽  
Hplc Method Development

A sensitive and precise HPLC procedure has been developed for the assay of amphotericin B in bulk samples and pharmaceutical formulations by using a C18 column [Kromosil, C18, (5 µm, 4.6mm x 250 mm; Make. Waters)], and mobile phase combination is 1% formic acid in water and acetonitrile in ratio of 45:55 V/V. The procedure has been validated as per the ICH guidelines. The λmax of detection was fixed at 407 nm, so that there was less interference from mobile phase with highest sensitivity according to UV analysis. Calibration plots were linear in the range of 10-100 µg/mL and the LOD and LOQ were 0.02 µg/mL and 0.06 µg/mL respectively. The high recovery and low relative standard deviation confirm the suitability of the method for routine quality control determination of amphotericin B in different formulations.

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LINAGLIPTIN AND EMPAGLIFLOZIN

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (05) ◽  
pp. 68-71
Author(s):  
A Lakshmana Rao ◽  
◽  
T. Prasanthi ◽  
E. L Anusha
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

A simple, accurate and precise RP-HPLC method was developed for the simultaneous estimation of the linagliptin and empagliflozin in tablet dosage form. Chromatogram was run through Kromasil 250 x 4.6 mM, 5mM column, mobile phase containing 0.1% o-phosphoric acid buffer and acetonitrile in the ratio of 60:40%v/v was pumped through column at a flow rate of 1 mL/min. The optimized wavelength was 230 nm. Retention times of linagliptin and empagliflozin were found to be 2.759 min and 2.139 min. %RSD of the Linagliptin and Empagliflozin were found to be 0.5 and 0.6 respectively. Percentage assay was obtained as 99.91% and 100.15% for linagliptin and empagliflozin, respectively. LOD, LOQ values obtained for linagliptin and empagliflozin were 0.23 μg/ml and 0.44 μg/mL and 0.70 μg/mL and 1.34 μg/mL, respectively. Thus, the current study showed that the developed RP-HPLC method is sensitive and selective for the estimation of linagliptin and empagliflozin in combined dosage form.

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