scholarly journals A NEW NP-UPLC METHOD FOR THE SEPARATION AND SIMULTANEOUS QUANTIFICATION OF RAMUCIRUMAB AND ERLOTINIB

2021 ◽  
pp. 75-81
Author(s):  
SIVA MADHU CHAITANYA ◽  
SRINATH NISSANKARARAO ◽  
SATYA LAKSHMI GANDHAM
Keyword(s):  
Liquid Chromatography ◽  
Dosage Form ◽  
Ultra Performance Liquid Chromatography ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Chiralcel Od ◽  
Successful Separation ◽  
Liquid Chromatography Method ◽  
Fine Resolution

Objective: This investigation demonstrates a stability-indicating and reliable “normal phase ultra-performance liquid chromatography” method to simultaneously quantify Ramucirumab and Erlotinib in the pharmaceutical dosage form. Methods: Successful separation was accomplished using Chiralcel-OD-3 column (50 mm x 4.6 mm, 3 μm) with an isocratic type of elution using a mobile phase containing n-hexane+isopropyl alcohol+methanol (89:10:1), respectively with 1.0 ml/min flow rate. The wavelength sensor was attuned at 266 nm to quantify Ramucirumab and Erlotinib. Results: Erlotinib and Ramucirumab peaks were eluted with fine resolution at retention times 1.7807 min and 3.175 min, respectively. In the 10-150 μg/ml and 1-15 μg/ml concentration ranges for Erlotinib and Ramucirumab, the calibration graphs were linear, with regression coefficients of 0.99928 and 0.99976, respectively. The suggested ultra-performance liquid chromatography approach has been shown as sensitive, precise, robust, accurate, specific and stability indicating through the resolution of Erlotinib and Ramucirumab from its degradation-based compounds. Conclusion: The established ultra-performance liquid chromatography technique was effectively extended to the evaluation of Erlotinib and Ramucirumab in the pharmaceutical dosage form and the test results appeared satisfactory.

scholarly journals Stability indicating Ultra Performance Liquid Chromatography method development and validation for simultaneous estimation of artemether and lumefantrine in bulk and pharmaceutical dosage form

2019 ◽  
Vol 9 (2) ◽  
pp. 217-221
Author(s):  
Bandari Sukanya ◽  
V Mohan Goud ◽  
P Anitha
Keyword(s):  
Liquid Chromatography ◽  
Dosage Form ◽  
Method Development ◽  
Ultra Performance Liquid Chromatography ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Liquid Chromatography Method ◽  
Tablet Dosage

Ultra performance liquid chromatography method was developed for the simultaneous estimation of the Artemether (AMT) and Lumefantrine (LFT) in Tablet dosage form. Chromatogram was run through X-bridge C18 100 x 2.1 mm, 3.5m. Mobile phase containing Buffer 0.01N KH2PO4 (3.5pH): Acetonitrile taken in the ratio 55:45 was pumped through column at a flow rate of 0.3ml/min. Buffer used in this method was 0.01N KH2PO4. Temperature was maintained at 30°C. Optimized wavelength selected was 215nm. Retention time of AMT and LFT were found to be 0.787 min and 1.572min. %RSD of the AMT and LFT were and found to be 0.7 and 0.6 respectively. %Recovery was obtained as 99.49% and 100.22% for AMT and LFT respectively. LOD, LOQ values obtained from regression equations of AMT and LFT were 0.03, 0.08 and 0.095, 0.288 respectively. Regression equation of AMT is y = 19308x + 1509 and y = 36919x + 11566 of LFT. The developed method was simple and economical that can be adopted in regular Quality control test in Industries. Keywords: Artemether (AMT), Lumefantrine (LFT), Acetonitrile, UPLC.

scholarly journals VALIDATED STABILITY INDICATING HPLC APPROACH FOR QUANTIFYING TRICHOLINE CITRATE AND CYPROHEPTADINE SIMULTANEOUSLY IN SYRUP FORMS

2021 ◽  
pp. 207-213
Author(s):  
MOHINISH SAHAI ◽  
N. DEVANNA
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Volume Ratio ◽  
Test Results ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Successful Separation ◽  
Liquid Chromatography Method ◽  
Fine Resolution

Objective: This investigation demonstrates a stability-indicating and reliable “high-performance liquid chromatography” method to simultaneously quantify tricholine citrate (TEC) and cyproheptadine (CRH) in the syrup form and bulk form. Methods: Successful separation was accomplished using C18 “Agilent column (250 mm × 4.6 mm, 5 μm)” with isocratic type of elution using mobile phase containing 0.1 M NaH2PO4 buffer and acetonitrile at 55% volume and 45% volume ratio, respectively with 1.0 ml/min flow rate. The wavelength sensor was attuned at 263 nm to quantify TEC and CRH. Results: TEC and CRH peaks were eluted with fine resolution at retention times 1.837 min and 2.936 min, respectively. In the 137.5-412.5 μg/ml and 1-3 μg/ml concentration ranges for TEC and CRH, the calibration graphs were linear, with regression coefficients of 0.9999 and 0.9998, respectively. The suggested "high-performance liquid chromatography" approach has been shown as sensitive, precise, robust, accurate, specific and stability indicating through the resolution of TEC and CRH from its degradation-based compounds. Conclusion: The established high-performance liquid chromatography technique was effectively extended to the evaluation of TEC and CRH in the combined syrup form and the test results appeared satisfactory.

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING REVERSE-PHASE HIGHPERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS OF REGADENOSON FROM ITS PARENTERAL DOSAGE FORM

2018 ◽  
Vol 11 (8) ◽  
pp. 277
Author(s):  
Murlidhar V Zope ◽  
Rahul M Patel ◽  
Ashwinikumari Patel ◽  
Samir G Patel
Keyword(s):  
Liquid Chromatography ◽  
Degradation Product ◽  
Mobile Phase ◽  
Dosage Form ◽  
Degradation Products ◽  
Reverse Phase ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Liquid Chromatography Method ◽  
Injectable Dosage

Objective: The objective was to develop and validate the stability indicating reverse-phase high-performance liquid chromatography method for the quantification of potential degradation products of regadenoson (REGA) from its injectable dosage form.Methods: YMC-PAK ODS AQ, 150 mm × 4.6 mm, 3 μm composed with hydrophobic high carbon loading and a relatively hydrophilic surface chemically bonded to porous silica particles column was used with the temperature maintained at 40°C. Mobile phase A composed of 0.1% triethylamine buffer having pH 4.5 while mobile phase B is 100 % acetonitrile was used for gradient elution with 1.5 ml/min as a flow rate. The wavelength used for quantification was 245 nm and 20 μl as an injection volume. The suitability of the method has been checked and validated according to the International Council for Harmonization (ICH) guidelines for different parameters, namely, specificity, linearity, accuracy, precision, limit of quantification (LOQ), Limit of detection (LOQ), and robustness studies.Results: The resolution between REGA and its two-degradation product is >8.0 for all pairs of components. The high correlation coefficient (r2>0.990) values are for drug and all potential degradation products from LOQ to 150% of specification limits for impurities calculated based on the maximum daily dose of REGA. LOQ for the drug as well as each degradation product is <0.02% w/w. The % relative standard deviation (RSD) for precision and intermediate precision is in the range of 0.17–0.89, and % RSD for precision at LOQ is 0.86–2.35. The % RSD for robustness study is maximum 2.59.Conclusion: The developed method can quantify the specified and unknown degradation products from 0.1% in the injectable dosage form which indicates that method is sensitive. Method fulfills the ICH criteria for its different validation parameters and demonstrates that the developed analytical method is highly specific, precise, and robust and would have a great value when applied in quality control and stability studies for REGA injection.

scholarly journals NEW STABILITY-INDICATING ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION OF LENVATINIB MESYLATE IN BULK DRUG AND PHARMACEUTICAL DOSAGE FORMS

2018 ◽  
Vol 11 (9) ◽  
pp. 140
Author(s):  
Jahnavi Bandla ◽  
S. Ganapaty
Keyword(s):  
Liquid Chromatography ◽  
Dosage Form ◽  
Ultra Performance Liquid Chromatography ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Relative Standard ◽  
Validation Parameters ◽  
Bulk Drug

Objective: The objective of the present study was to develop and validate a new stability-indicating method for the quantification of lenvatinib mesylate in bulk drug and pharmaceutical dosage form using ultra performance liquid chromatography (UPLC).Methods: The optimized chromatographic conditions for elution of drug included UPLC HSS C18 (100 mm × 2.1 mm, 1.8 m) column, mixture of 0.1% orthophosphoric acid and acetonitrile (50:50 v/v%) mobile phase run on an isocratic mode at a flow rate of 0.3 mL/min, 240 nm detection wavelength, and column oven temperature maintained at 30°C.Results: The retention time for lenvatinib was found to be 1.24 min. The developed method was validated for various validation parameters in accordance with the International Conference on Harmonization guidelines. The method obeyed Beer’s law in the concentration range of 2.5– 15 μg/mL with a correlation coefficient of 0.9996. The percentage relative standard deviation and percentage recovery were determined to be 0.4 and 99.66–100.30%, respectively. The developed method was found to be accurate, precise, specific, linear, rugged, and robust. Forced degradation studies were conducted by exposing the drug to diverse stress conditions such as acidic, basic, peroxide, neutral, photolytic, and thermal conditions. The net degradation was obtained within the limits.Conclusion: The developed method for the estimation of lenvatinib can be employed to routine analysis of pharmaceutical dosage form.

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