scholarly journals Development and Validation of the Quantification Method for Hydroxychloroquine in Volumetric Absorptive Microsampling (VAMS) Using High-Performance Liquid Chromatography-Photodiode Array

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Yahdiana Harahap ◽  
Siti Ardyanti Rohadatul ‘Aisy ◽  
Baitha Palanggatan Maggadani

Hydroxychloroquine is an antimalarial drug used for systemic lupus erythematosus, rheumatoid arthritis, and malaria treatment. However, hydroxychloroquine has several side effects such as ocular toxicity, neurotoxicity, gastrointestinal disorder, and also severe toxicity such as cardiotoxicity. Therefore, therapeutic drug monitoring of high dose or long-term use of hydroxychloroquine is needed. This study aims to obtain an optimum and validated analysis and preparation method for hydroxychloroquine in volumetric absorptive microsampling (VAMS) using the high-performance liquid chromatography–photodiode array detector based on the Food and Drug Administration guidelines (2018). Hydroxychloroquine quantification was performed using HPLC-PDA with Waters Sunfire™ C18 (5 µm; 250 × 4,6 mm) column. Mobile phase consists of acetonitrile-diethylamine 1% (65 : 35, v/v) (isocratic elution) and delivered at a flow rate of 0.8 mL/min throughout the 12 minutes run. Sample in VAMS is extracted by liquid-liquid extraction with ammonia 1% and n-hexane-ethyl acetate (50 : 50 v/v) as a extraction solvent. This method has successfully qualified the Food and Drug Administration (2018) parameters, with 2 ng/mL of LLOQ, range of calibration curve 2–6500 ng/mL, and coefficient of correlation 0.9993–0.9997.

Author(s):  
Kanan G Gamit ◽  
Niraj Y Vyas ◽  
Nishit D Patel ◽  
Manan A Raval

Objective: A study was aimed to estimate guggulsterone-Z (GZ) in Gokshuradi Guggulu (GG).Methods: An analytical method was developed and validated using Waters Alliance high-performance liquid chromatography system (Empower software), equipped with photodiode array detector. Separation was achieved using Phenomenex, C-18 (250 mm×4.6 mm, 5 μ) column. Mobile phase consisted of acetonitrile:water (70:30,v/v). Flow rate was set to 1 ml/min and detection was performed at 251 nm.Results and Discussion: Validation parameters such as linearity, precision, accuracy, limit of detection, limit of quantification, and robustness were performed. Amount of GZ was estimated using linearity equation.Conclusion: GG was found to contain 0.815±0.03 g% w/w GZ. Validated method may be used as one of the parameters to standardize the formulation.


2018 ◽  
Vol 13 (11) ◽  
pp. 1934578X1801301
Author(s):  
Chang-Seob Seo ◽  
Hyeun-Kyoo Shin

The root bark of Morus alba L. (Family: Moraceae) is an important medicinal herb in many countries and has long been used as a traditional medicine for the treatment of cough, fever, blood pressure reduction, and respiratory diseases. In the present study, the simultaneous determination of two flavonoids, kuwanon G and morusin, for quality control of M alba was conducted using high-performance liquid chromatography (HPLC) equipped with photodiode array (PDA) detector. The column used for separation of kuwanon G and morusin was a Gemini C18 analytical column maintained at 45°C. The mobile phase for efficient separation of two analytes was flowed 0.1% (v/v) aqueous formic acid-acetonitrile with gradient elution. The detection wavelength for quantification was set at 266 nm. The optimized method showed good linearity with coefficients of determination of 0.9998 within the tested concentration ranges. The limits of detection for the two flavonoids, kuwanon G and morusin, were 0.69 μg/mL and 0.35 μg/mL and the limits of quantification of kuwanon G and morusin, were 2.10 μ/mL and 1.07 μg/mL. The recoveries were 98.40–111.55% and the relative standard deviation (RSD) value was within 3.50%. The RSD values of intra- a g d interday precisions were 0.08–0.70% and 0.06-0.48%, respectively. The amounts of kuwanon G and morusin were 1.94-2.26 mg/g and 1.05–1.12 mg/g. The established HPLC-PDA method will help to improve the quality control of M. alba and related products.


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