Development and validation of a stability-indicating ultra-performance liquid chromatography (UPLC) method for doxycycline hyclate: an optimization of the analytical methodology for a medical countermeasure (MCM) drug

2018 ◽  
Vol 10 (16) ◽  
pp. 1842-1851 ◽  
Author(s):  
Adil Mohammad ◽  
Cheng H. Yen ◽  
Miah Schneider ◽  
Bryan Lowry ◽  
Firat Yerlikaya ◽  
...  

Doxycycline hyclate drug product impurities and rapid quantification using a validated UPLC method.

Author(s):  
SIVA MADHU CHAITANYA ◽  
SRINATH NISSANKARARAO ◽  
SATYA LAKSHMI GANDHAM

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.


2021 ◽  
Vol 11 (6) ◽  
pp. 86-91
Author(s):  
Sachin N. Kapase

For qualitative and quantitative analysis, various analytical techniques are available such as Ultraviolet (UV) Spectrophotometry, High-performance liquid chromatography (HPLC), High-performance thin layer chromatography (HPTLC). As per literature survey, there are some UV, HPLC, Ultra-Performance Liquid Chromatography (UPLC) and HPTLC analytical methods are developed for Montelukast and Doxofylline individually and in a combination with other drugs too, since yet there are no significant stability studies indicating HPLC method reported for Montelukast and Doxofylline combinations. In the current study, the HPLC method is developed and validated for simultaneous quantitative estimations of Montelukast and Doxofylline. These present techniques are more efficient and sensitive as compared to other analytical techniques.


2010 ◽  
Vol 93 (2) ◽  
pp. 389-399 ◽  
Author(s):  
Alaa Kamel ◽  
Yaorong Qian ◽  
Elizabeth Kolbe ◽  
Charles Stafford

Abstract A multiresidue method was developed and validated for the determination of 13 neonicotinoid pesticides and metabolites, and nine macrocyclic lactone pesticides and veterinary drugs using SPE and ultra-performance liquid chromatography/MS/MS. The method was validated in milk, orange, spinach, apple, plum, watermelon, green bean, zucchini, broccoli, strawberry, grape, and tomato by analyzing replicates of residue-free control samples fortified with a mixture of 22 target analytes at three concentration levels. The recoveries of the analytes from the fortified matrixes were mostly within 70120, except for some of the neonicotinoid metabolites. The LOD values varied by analyte and matrix and ranged between 0.0012 ng/g. The developed method was successful in combining two widely different classes of compounds into a single analysis.


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