scholarly journals An Internal Standard High-Performance Liquid Chromatography Method for Simultaneous Quantification of Candesartan and Hydrochlorothiazide in Combined Formulations

2021 ◽  
Vol 37 (5) ◽  
pp. 1077-1082
Author(s):  
Faisal K. Algethami

The internal standard method is a versatile procedure that avoids misleading results caused by the instability of the chromatographic system or inexperienced workers. It is an effective way to judge the accuracy of any obtained data. As the detector responses of chlorzoxazone (CZN) resemble those of candesartan (CDZN) and hydrochlorothiazide (HCTZ), CZN was employed as an internal standard. Herein, a simple chromatographic method was established for quantification of CDZN and HCTZ. Isocratic elution was conducted using 1% premixed acetonitrile/formic acid (7:3 v/v) at a 0.8 mL/min flowrate. The separation of the three components was maintained using the universal 20 µL loop, and for further simplicity in application, the analysis was optimized at 25 °C. CDZN, HCTZ, and CZN were simultaneously monitored and quantified at 270 nm. The method developed here complies with all the validation limits according to the British Pharmacopoeia (BP), United States Pharmacopoeia (USP), and the guidelines of the International Council ForHarmonisation (ICH). The method proved to be linear in the range of 6.4 to 25.6 µg/mL and 5.0–20 µg/mL for CDZN and HCTZ, respectively, while the quantitation detection limits were less than 1.0µg/mL for both.

2011 ◽  
Vol 8 (4) ◽  
pp. 1620-1625 ◽  
Author(s):  
Deshmukh Hafsa ◽  
S. Chanda ◽  
Pradnya J. Prabhu

A rapid and simple high performance liquid chromatography method was developed and validated at λ=275 nm for simultaneous determination of methocarbamol, paracetamol and diclofenac sodium (lamotrigine as an internal standard) from pharmaceutical preparation. The separation was performed using methanol: water: GAA, in the ratio of 400:600:05 (v/v) as the mobile phase. The detector response was linear in the range of 5 to 45 μg, 3.25 to 29.25 μg, 0.5 to 4.5 μg for methocarbamol, paracetamol and diclofenac sodium respectively. The percentage assay of methocarbamol, paracetamol and diclofenac sodium was found between 100, 99.76 and 99.31% respectively. The described method has the advantage of being rapid and easy hence it can be applied for routine quality control analysis.


2010 ◽  
Vol 54 (8) ◽  
pp. 3408-3413 ◽  
Author(s):  
Lorena Baietto ◽  
Antonio D'Avolio ◽  
Giusi Ventimiglia ◽  
Francesco Giuseppe De Rosa ◽  
Marco Siccardi ◽  
...  

ABSTRACT We have developed and validated a high-performance liquid chromatography method coupled with a mass detector to quantify itraconazole, voriconazole, and posaconazole using quinoxaline as the internal standard. The method involves protein precipitation with acetonitrile. Mean accuracy (percent deviation from the true value) and precision (relative standard deviation percentage) were less than 15%. Mean recovery was more than 80% for all drugs quantified. The lower limit of quantification was 0.031 μg/ml for itraconazole and posaconazole and 0.039 μg/ml for voriconazole. The calibration range tested was from 0.031 to 8 μg/ml for itraconazole and posaconazole and from 0.039 to 10 μg/ml for voriconazole.


2019 ◽  
Vol 57 (10) ◽  
pp. 910-919
Author(s):  
Aymen Labidi ◽  
Latifa Latrous El Atrache

Abstract A new ultra-high-performance liquid chromatography method for the simultaneous quantification of sofosbuvir, daclatasvir and ledipasvir was developed. Two combinations of these direct-acting antivirals are used in hepatitis C virus infection therapy and show high efficacy and safety. Fractional factorial design was used for screening the most influential factors on separation and time analysis. These significant factors were optimized using a central composite design. The optimum resolution was carried out by using a Waters XBridge C18 column (150 mm, 4.6 mm ID, 5 μm) at a temperature of 35°C ± 2°C and acetonitrile/sodium perchlorate buffer (10 mM, pH = 3.2) (40: 60 v/v) as mobile phase at a flow rate of 1.5 mL min−1. UV detection was set at λ = 210 nm. A short chromatographic separation time was achieved. The developed method was validated according to the accuracy profile approach and was found specific, precise, faithful and accurate. The detection limits were between 0.07 and 0.13 μg mL−1. Hence, this novel method can be employed for the routine quality control analysis and in dissolution profile studies of generics containing these products.


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