Front Cover: Development and Validation of Reverse‐Phase High‐Performance Liquid Chromatography Method for Estimation of Itraconazole through Hydroxypropyl Methylcellulose Acetate Succinate based Polymeric Films using Quality by Design principles

2021 ◽  
Vol 4 (11-12) ◽  
Author(s):  
Shantanu Damle ◽  
Manisha Choudhari ◽  
Gautam Singhvi ◽  
Ranendra Narayan Saha ◽  
Sunil Kumar Dubey
Author(s):  
Anjoo Kamboj ◽  
Manisha Bhatti ◽  
Pooja Atri

ABSTRACTObjective: Xanthium strumarium is a cocklebur or burweed belonging to family Asteraceae and commonly found as a weed, is widely distributed inNorth America, Brazil, China, Malasia, and hotter part of India. The herb is traditionally used mostly in treating several ailments. The present studydeals with development and validation of a reliable reverse phase high-performance liquid chromatography (RP-HPLC) method for the simultaneousestimation of Stigmasterol and β-sitosterol in the various extracts of the plant.Methods: The proposed method utilizes a Qualisil Gold C18 column (250×4.6 mm), 5 µm particle size, under isocratic elution conditions with themixture of acetonitrile:ethanol:water (85:14:1 v/v/v) at 25° as a mobile phase. An effluent flow rate of 1 ml/minute and ultraviolet detection at202 nm was used for the analysis of Stigmasterol and β-sitosterol.Results: The described method was linear in the range of range of 100-500 µg/ml and 10-500 µg/ml for stigmasterol and β-sitosterol respectively,with excellent correlation coefficients. The precision, robustness, and ruggedness values were also within the prescribed limits (<2%). The recoveryvalues were within the range, which indicates that the accuracy of the analysis was good and that the interference of the matrix with the recovery ofphytosterols was low. The phytosterols were found to be stable in a stock solution for 24 hrs (percentage relative standard deviation was below 2%)and no interfering extra peaks were observed under controlled stress conditions.Conclusion: The proposed method is simple, specific, precise, accurate, and reproducible and thus can be used as appropriate method for routineanalysis of X. strumarium phytosterols in quality control laboratories.Keywords: Xanthium strumarium, Reverse phase high-performance liquid chromatography method, Precision, Phytosterols, Quality control.


Author(s):  
R. S. Dave ◽  
Vipul J. Vyas ◽  
Bipinchandra Mahyavanshi

The study was focused toward synthesis, characterization and quantification of Pyridine derivative by Reverse Phase High Performance Liquid Chromatography method. The synthesis of novel pyridine derivative was carried out by condensation reaction in presence of inert catalyst K2CO3 and THF solvent. Characterization was done by I.R, 1H-NMR,and HPLC. Based on the spectral data, the structure of novel pyridine derivative was characterized as 5 - (4 - Substituted amino) - 3- Nitrobenzene - 1 - Sulfonyl) - 4, 5, 6, 7 –Tetrahydrothieno[3, 2 - C] Pyridine The method validation including precision, accuracy, LOD, robustness, Linearity, and range was developed as per ICH guideline through an efficient isocratic RP-HPLC.It was determined that the above procedure is specified, accurate, precise, robust, and sturdy.


INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (01) ◽  
pp. 35-40
Author(s):  
A. S. Bagde ◽  
V. V. Khanvilkar ◽  

The present work describes a validated reverse phase high performance liquid chromatography (RPHPLC) method for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate in pharmaceutical dosage from. The drugs were resolved using Hemochrom Intsil C18-5U column (250×4.6) mm in isocratic mode with mobile phase methanol: water (0.08% diethylamine, 0.02% of glacial acetic acid and pH 4.4 adjusted with orthophosphoric acid) in the ratio of 70:30 V/V at a flow rate of 1.0 mL/min. Retention time of dextromethorphan hydrobromide and quinidine sulphate were 4.9±0.2 and 3.6±0.2, respectively, at 292nm. The above mentioned method was validated as per International Conference on Harmonization (ICH) guidelines. Linear responses were obtained in concentration ranges of 5-35 μg/mL for dextromethorphan hydrobromide and 4-16 μg/mL for quinidine sulphate, with correlation coefficient (r2) of 0.999 for both the drugs. A simple, selective, accurate, precise, robust and reliable RP-HPLC method thus developed and validated for simultaneous estimation of dextromethorphan hydrobromide and quinidine sulphate.


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