scholarly journals Strategic Combination of Isocratic and Gradient Elution for Simultaneous Separation of Polar Compounds in Traditional Chinese Medicines by HPLC

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Mei-Tuo Zhang ◽  
Xiao-Xue Ye ◽  
Wei Lan ◽  
Yan-Ling Yang ◽  
Tsunghsueh Wu ◽  
...  
Keyword(s):  
High Performance ◽  
Gradient Elution ◽  
Polar Compounds ◽  
Hplc Method ◽  
Traditional Chinese Medicines ◽  
Chinese Medicines ◽  
Polar Components ◽  
Simultaneous Separation ◽  
Gradient Separation ◽  
Isocratic And Gradient Elution

A simple high-performance liquid chromatography (HPLC) method for the simultaneous separation of the highly polar and weakly polar components of traditional Chinese medicines was developed via a strategic combination of isocratic and gradient elution methods. Liu-Shen-Wan and Liu-Wei-Di-Huang-Wan were used as representative examples of traditional Chinese medicines. This is the first time that 6 components of varying degrees of polarity in Liu-Shen-Wan had been successfully resolved in a single chromatographic run using an ultraviolet-visible detector with a fixed wavelength of 296 nm. In contrast to conventional gradient separation methods, this novel method offered a viable route for separation of the highly and weakly polar fractions simultaneously, thus greatly reducing the time and cost of analysis. This method therefore provides a more efficient way to determine the polar components present in traditional Chinese medicines. It would find potential application in drug screening, drug authentication, and product quality control.

OPTIMISATION AND VALIDATION OF HPLC METHOD FOR SIMULTANEOUS QUANTIFICATION OF RIFAMPICIN, ISONIAZID, PYRAZINAMIDE, AND ETHAMBUTOL HYDROCHLORIDE IN ANTI-TUBERCULOSIS 4-FDC TABLET

2015 ◽  
Vol 77 (1) ◽  
Author(s):  
Sholihul Khoiri ◽  
Sudibyo Martono ◽  
Abdul Rohman
Keyword(s):  
High Performance ◽  
Phosphate Buffer Solution ◽  
Gradient Elution ◽  
Hplc Method ◽  
Fixed Dose ◽  
Buffer Solution ◽  
Solution Ph ◽  
Combination Tablet ◽  
Simultaneous Quantification ◽  
Dose Combination

High-performance liquid chromatography (HPLC) method has been developed and validated for the simultaneous quantification of four components, namely rifampicin (RIF), isoniazid (INH), pyrazinamide (PYR), and ethambutol hydrochloride (ETM), contained in anti-tuberculosis drugs in fixed dose combination tablet (4-FDC). In order to increase the sensitivity of EMB, the pre-column derivatization technique with phenethyl isocyanate (PEIC) was carried out. The separation was accomplished using Waters Symmetry C8 (250× 4.6 mm i.d.; 5 μm) at 30oC. The mobile phase used was a mixture of acetonitrile and 20 mM phosphate buffer solution (pH 6.8) containing triethylamine and delivered at 1.5 mL/minute using gradient elution. TheUV detector was set at 210 nm. The method was validated in terms of selectivity, linearity, accuracy, precision, detection limit, quantification limit, and robustness according to International Conference on Harmanization (ICH). The optimized method is succcesfully used for quantitative analysis of RIF, INH, PYR and ETM in 4-FDC tablets. The level of these drugs in 4-FDC tablets were in accordance to that specified in Indonesian pharmacopeia.

Validation of HPLC Method for Determination of Histamine in Human Immunoglobulin Formulations

2020 ◽  
Vol 103 (5) ◽  
pp. 1223-1229
Author(s):  
Michikazu Tanio ◽  
Toru Nakamura ◽  
Hideki Kusunoki ◽  
Kyohei Ideguchi ◽  
Kazuyuki Nakashima ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Standard Deviation ◽  
High Performance ◽  
Gradient Elution ◽  
Hplc Method ◽  
Human Immunoglobulin ◽  
Histamine Dihydrochloride ◽  
Relative Standard

Abstract Background Histamine fixed-immunoglobulin formulations, which consisted of 0.15 µg of histamine dihydrochloride and 12 mg of human immunoglobulin in a vial, are used for anti-allergic treatments, and controlling the amounts of histamine in the formulations is essential to avoid histamine intoxication. Objective A high-performance liquid chromatography (HPLC) method for determination of histamine contents of the formulations was established and validated. Methods Histamine extracted from the formulation was labeled with 6-aminoquinolyl-N-hydroxysuccinimidyl carbamate and was analyzed by gradient elution HPLC with UV detection at 260 nm. Results The method showed linearity in the range 0.8–2.4 µM (R > 0.999), accuracy (100.1–105.8% recovery), and precision (relative standard deviation ≤ 1.93%). The validated method was applied for five lots of the pharmaceutical, and their histamine contents were determined to be 0.149–0.155 µg/vial. Conclusions These results indicated that the validated method is useful to control amounts of histamine in biopharmaceutical products. Highlights The HPLC method was developed for quantitative determination of histamine content of the histamine fixed-immunoglobulin formulations.

scholarly journals Simultaneous determination of mycophenolic acid and its glucuronide in human plasma using a simple high-performance liquid chromatography procedure

1998 ◽  
Vol 44 (7) ◽  
pp. 1481-1488 ◽  
Author(s):  
Maria Shipkova ◽  
Paul Dieter Niedmann ◽  
Victor William Armstrong ◽  
Ekkehard Schütz ◽  
Eberhard Wieland ◽  
...  
Keyword(s):  
Mycophenolic Acid ◽  
High Performance ◽  
Internal Standard ◽  
Gradient Elution ◽  
Reversed Phase ◽  
Hplc Method ◽  
Free Concentration ◽  
Elution Chromatography ◽  
Glucuronide Metabolite

Abstract We describe a reversed-phase HPLC method for determination of total mycophenolic acid (MPA), its free concentration (MPAf), and the glucuronide metabolite (MPAG), based on simple sample preparation and gradient elution chromatography. The compounds were quantified in parallel by absorbance at 254 nm and 215 nm in the internal standard mode. Linearity was verified up to 50 mg/L for MPA and up to 500 mg/L for MPAG (r >0.999). Detection limits at 215 and 254 nm were, respectively, 0.01 and 0.03 mg/L for MPA, and 0.03 and 0.1 mg/L for MPAG. The recovery of MPA was 95–106%;recovery of MPAG was 96–106%. The imprecision (CV) for MPA (0.2–25 mg/L) was <8.4% (254 nm) and <4.4% (215 nm) within day (n = 12) and <9.2% (254 nm) and <6.2% (215 nm) between days (n = 12). The imprecision for MPAG (10–250 mg/L) was <4.9% (254 nm) and <3.4% (215 nm) within day, and <6.1% (254 nm) and <5.9% (215 nm) between days. For quantification of MPAf, 100 μL of ultrafiltrate was applied directly to the column. The detection limit was 0.005 mg/L at 215 nm and 0.015 mg/L at 254 nm. In the range between 18–210 μg/L, the within-day CVs were <11.8% (n = 12) and the between-day CVs were <15.8% (n = 12).

scholarly journals Simultaneous Determination of Eight Synthetic Permitted and Five Commonly Encountered Nonpermitted Food Colors in Various Food Matrixes by High-Performance Liquid Chromatography

2010 ◽  
Vol 93 (5) ◽  
pp. 1503-1514 ◽  
Author(s):  
Sumita Dixit ◽  
Subhash K Khanna ◽  
Mukul Das
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
High Sensitivity ◽  
Gradient Elution ◽  
Reversed Phase ◽  
Hplc Method ◽  
Food Category ◽  
Food Commodities ◽  
Food Colors

Abstract A simple and sensitive HPLC method has been developed for the simultaneous determination of eight permitted food colors and five commonly encountered nonpermitted colors in various food commodities, including sugar-, fat-, and starch-based food matrixes. The method uses a specific food category-based cleanup/treatment procedure before color extraction to avoid the interference of food matrixes, and to obtain the optimal color extraction. Analysis was performed on a reversed-phase C18 -Bondapak column with ammonium acetate and acetonitrile gradient elution as the mobile phase; a programmable max-specific visible detection was used to monitor colors to obtain the higher sensitivity and expanded scope needed for multicolor blends having diverse absorption maxima. All colors showed good linearity, with regression coefficients of 0.99740.9999. The LOD and LOQ values ranged from 0.01 to 0.12 mg/L, and from 0.04 to 0.83 mg/L or mg/kg, respectively. The intraday and interday precision tests produced good RSD values, and the recoveries from different food matrixes ranged from 82 to 104%. The method offers high sensitivity for analysis of a wide variety of food matrixes containing a broad scope of multicolor blends. Two nonpermitted colors, orange II and metanil yellow, were found. Also, a number of samples contained permitted colors at levels two-to seven-fold higher than those prescribed.

scholarly journals Qualitative and quantitative evaluation of melittin in honeybee venom and drug products containing honeybee venom

2013 ◽  
Vol 57 (2) ◽  
pp. 37-44 ◽  
Author(s):  
Ghasem Haghi ◽  
Alireza Hatami ◽  
Mehdi Mehran
Keyword(s):  
High Performance ◽  
Pure Water ◽  
Gradient Elution ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Honeybee Venom ◽  
Drug Products ◽  
Rp Hplc ◽  
Validation Parameters ◽  
Main Component

Abstract A reverse-phase high-performance liquid chromatographic (RP -HPLC ) method was developed and validated for the analysis of honeybee venom samples and drug products containing honeybee venom. The validation parameters were linearity, sensitivity, precision, and recovery. Melittin is the main component of honeybee venom was extracted with pure water, and then evaluated by RP -HPLC with a photodiode array (PDA ) detector. Separation of the samples was achieved on a Europa Protein C18 column with linear gradient elution of acetonitrile and 0.4% phosphoric acid at 25°C. There was a flow rate of 1 mL/min. Detection was set at 220 nm. Limits of detection (LOD ) and quantification (LO Q) for melittin were 1.1 and 3.2 μg/mL, respectively. The amount of melittin in honeybee venom samples ranged from 21.9 to 66.4 %.

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