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1

Quantitative evaluation and chromatographic fingerprinting for the quality assessment of Pudilan tablet

Lu Mengya, Tang Qianqian, Zhou Chenyu, Fang Zhizheng, Fan Zheng, Li Xiangyu, Han Rongchun, Tong Xiaohui

Acta Chromatographica

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2023

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Vol. 35, no. 4

338--346

EN

An easy, quick, and sensitive approach adopting ultra-performance liquid chromatography (UPLC) equipped with diode array detector was used to analyze and systematically evaluate the quality of Pudilan tablets manufactured by 12 distinct pharmaceutical companies. In this research, 15 peaks were chosen as the common peaks to assess the similarities for different batches (S1–S43) of Pudilan tablet samples. In comparison with the control fingerprint, similarity values for 43 batches of samples exceeded 0.922. In addition, by analyzing the reference substances of epigoitrin, caffeic acid, chlorogenic acid, acetylcorynoline, baicalin and baicanshialein, the chromatogram of the 6 reference substances was established. The recoveries for the reference substances which demonstrated good regression in the linear range (r2 > 0.999) were in the range of 98.3–101.1%. The results demonstrated that the established method was highly accurate, efficient and reliable. This study provides a valid, dependable and pragmatic method to evaluate the quality of Pudilan tablet.

2

Estimation of pitavastatin and ezetimibe using UPLC by a combined approach of analytical quality by design with green analytical technique

Chanduluru Hemanth Kumar, Sugumaran Abimanyu

Acta Chromatographica

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2022

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Vol. 34, no. 3

361--372

EN

The current study explores a design and development of the simple, fast, green and selective novel method of UPLC to quantify pitavastatin and ezetimibe simultaneously. The combined approach of Green Analytical Method with Quality by Design-based risk assessment was done using the Ishikawa fishbone diagram followed by a rotatable central composite design used for the optimization. The optimal chromatographic separation was attained through a mobile phase of 72: 28% v/v ethanol and 0.1% orthophosphoric acid (pH 3.5), with a 0.31 mL min⁻¹ flow rate. The developed UPLC-PDA method was sensitive and specific for pitavastatin and ezetimibe, with linearity ranging from 2 to 30, 10–150 μg mL⁻¹ with an R2 of 0.9999 and 0.9997, respectively. The forced degradation study of stability-indicating assay results shows the degradation in respective stress conditions. The developed UPLC method was validated and found to have sensible results with good linearity, accuracy and precision. Further, the greenness was evaluated using five states of art metrics like NEMI, GAPI, AES, AMGS, and AGREE metrics and found the greenest results. Based on the results we concluded that the developed UPLC method could be efficient for the simultaneous determination of pitavastatin and ezetimibe in bulk and tablet dosage.

3

An improved UPLC method for determining uric acid in rat serum and comparison study with commercial colorimetric kits

Wen Shaoshi, Zhang Zixin, Chen Xiaopeng, Liu Jinchang, Yu Haiyang, Han Lifeng, Jin Lijun, Zhang Yi, Wang Tao

Acta Chromatographica

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2019

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Vol. 31, no. 3

201--205

EN

Uric acid (UA) is the final product of purine metabolism in humans. Elevated serum UA levels lead to the development of hyperuricemia, gout, kidney diseases, and metabolic syndrome. Accurate determination of UA plays a critical role in clinical diagnosis and laboratory investigation. An ultra-performance liquid chromatography (UPLC) with ultraviolet detection method has been developed and validated for UA analysis. Separation was achieved by a Waters ethylene bridged hybrid (BEH) Amide column (50 mm × 2.1 mm i.d., 1.7 μm) with acetonitrile and 0.1% acetic acid in deionized water in the proportion of 90 to 10 (v/v) as the mobile phase. The limit of detection and limit of quantification were 0.09 and 0.18 μmol/L, respectively. The method was validated by evaluating recovery (98.37–104.20%), accuracy (0.47–0.90%), and precision (1.24–1.81% for intra-batch and 1.76–3.98% for inter-batch). This method was then applied to UA determination in rat serum of hyperuricemia model. The results from UPLC, high-performance liquid chromatography (HPLC), and uric acid kits (phosphor-tungstic acid-based kit and uricase-based kit) were compared. The UPLC results were in very good agreement with HPLC. The developed method could be employed as a useful tool for the determination of UA in biofluids.

4

Establishment of a rapid method to quantify eight flavonol glycosides for quality assessment of red toon using UPLC

Shen Y., Xu M., Deng P., Gu Q., Yin H., Xia G., Jia X., Yang H., Tam J.

Acta Chromatographica

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2018

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Vol. 30, no. 1

31--37

EN

Red Toon is a popular vegetable of favorable health benefits over Asia and Russia regions. In this study, isolation and identification of chemical constituents were performed to assess the quality of this functional food cultivated in various origins or harvested in different months. As a result, eight flavonol glycosides including rutin (I), myricitrin (II), quercetin-3-O-β-d-galactoranoside (III), quercetin-3-O-β-d-glucopyranose (IV), quercetin-3-O-α-l-arabinopyranoside (V), astragalin (VI), quercetin-3-O-α-l-rhamopyranoside (VII), and kaempferol-3-O-α-l-rhamopyranoside (VIII) were obtained. Among these, compounds III and V were isolated from Toona genus for the first time. Importantly, a rapid and convenient ultra-performance liquid chromatography (UPLC) method was developed to quantify the flavonol glycosides in Red Toon and validated for linearity, precision, stability, repeatability, and accuracy successively. In addition, it was found that total flavonoid glycosides (about 2.6%) in the food were kept at a higher level from April to June than other months of the year. Furthermore, their content in the Red Toon collected from ten different origins was also determined and compared, and the results suggested that the total flavonoid glycosides from Shandong Yantai were the highest, followed by Shandong Ximou, supporting a well-recognized viewpoint that Red Toon cultivated in Shandong Province, China, is considered genuine due to the best health benefits and flavor.

5

HPLC and UPLC Analyses of Acetoin in Bacterial Culture Fluid

Fedorova E. N., Kivero A. D., Geraskina N. V., Ptitsyn L. R.

Acta Chromatographica

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2015

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Vol. 27, no. 4

613--622

EN

A simple and rapid ultra-performance liquid chromatographic (UPLC) method for analyzing acetoin in bacterial culture fluid was developed and validated for the first time. The samples were separated using an Acquity BEH C18 column (2.1 mm × 100 mm, 1.7 μm particle size) and isocratic elution with 30 mM phosphoric acid—1% acetonitrile as the mobile phase. A photodiode array detector (PDA) was used. The run time was 6 min, and the detection limit was 2.11 × 10−4 mg mL−1. The UPLC method was compared with high-pressure liquid chromatography (HPLC) for acetoin analysis. The proposed UPLC method is highly sensitive and was successfully applied to the analysis of acetoin in bacterial culture fluid.

6

Development of a New UPLC Method for Simultaneous Determination of Valsartan, Amlodipine Besylate, and Hydrochlorothiazide Pharmaceutical Products

Lahsini R., Monser L.

Acta Chromatographica

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2015

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Vol. 27, no. 3

449--460

EN

A new ultra-performance liquid chromatography method for the simultaneous determination of valsartan, amlodipine besylate, and hydrochlorothiazide in pharmaceutical formulations has been developed. Chromatographic separation was achieved within 1 min on a sub-2 μm RP18 column using an isocratic mode mobile phase consisting of a mixture of methanol and phosphate buffer (0.05 M, pH 3 ± 0.05) in the ratio 70:30 (v/v). The flow rate was set at 0.3 mL min-1 with a detection wavelength of 239 nm. The method was validated over the concentration ranges from 6.5 to 15.0 μg Ml -1 for hydrochlorothiazide, from 5.0 to 12 μg Ml-1 for amlodipine besylate and from 76.5 to 178.5 μg Ml-1 for valsartan. Calibration plots were linear for valsartan, amlodipine besylate, and hydrochlorothiazide with a correlation coefficient greater than 0.99. Relative variation coefficients for repeatability and reproducibility were less than 3.0%. Recoveries from standard addition essay of individual component in pharmaceutical formulations were varied from 97.0% to 102.0%. The proposed method was successfully applied for the determination of valsartan, amlodipine besylate, and hydrochlorothiazide in pharmaceutical formulations with recoveries with respect to label amount in pharmaceutical formulations that varied from 98.0% to 102.9%. The low flow rate, short analysis time, and simple mobile phase composition make the method cost effective, rapid, nontedious, and successfully employed for simultaneous determination of these drugs in commercial pharmaceutical products.

7

Development of an UPLC-QTOF-MS method for qualitative and quantitative analysis of Saussurea eopygmaea

Liao Z. X., Zhang B. B., Ding L. S., Zhou Y.

Acta Chromatographica

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2013

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Vol. 25, no. 1

171--180

EN

An ultra-performance liquid chromatography-quadrupole time-of-flight mass spectrometry UPLC-QTOF-MS method has been developed for qualitative and quantitative analysis major compounds in Saussurea eopygmaea Hand-Mazz, which has long been used as a traditional Tibetan medicine. This method was validated to be sensitive, precise, and accurate with the limits of detection of compounds 2,3,4,6, and 7 with 0.67–1.90 μg mL -1, the overall intra-day and inter-day variations less than 8.45%, and the overall recovery over 93.8%, respectively. The correlation coefficients (R2) of the calibration curves were higher than 0.998. In addition, by comparison MS and MS/MS spectra with those of authentic compounds and literatures, a total of 14 main peaks were identified within 6 min. These results demonstrate that this approach has the potential for quality control of S. eopygmaea and other Tibetan herbal medicines.

8

UPLC separation and quantification of related substances of varenicline tartrate tablet

Satheesh B, Kumarpulluru S, Raghavan V, Saravanan D

Acta Chromatographica

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2010

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Vol. 22, no. 2

207--218

EN

A new ultra-performance liquid chromatographic (UPLC) method has been developed and validated for quantification of substances related to varenicline tartrate, process-related and degradation products, in pharmaceutical formulations. Chromatographic separation of six impurities was performed on a reversed phase column. The method was validated for linearity, limits of detection and quantification, accuracy, precision, and selectivity. The calibration plots obtained for the six impurities were linear over the range 0.005–0.30%. The relative standard deviations ( s r ) of intra and inter-day experiments were less than 1.0%. The detection limits ranged between 0.002 and 0.004%, depending on the impurity. The proposed UPLC method was successfully applied to quantification of varenicline impurities in its pharmaceutical formulation.

9

UPLC analysis of common parabens in cosmetic products

Mincea M, Lupşa I, Talpoş I, Ostafe V

Acta Chromatographica

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2009

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Vol. 21, no. 4

591--602

EN

A simple and rapid ultra-performance liquid chromatographic (UPLC) method for analysis of parabens in cosmetic products has been developed and validated. Four preservatives (methylparaben, ethylparaben, propylparaben, and butylparaben) were extracted by ultrasonication with methanol. Separation was achieved by use of a C18 column (2.1 mm × 50 mm i.d.,1.7 μm particle size) and gradient elution with methanol-water-phosphoric acid as mobile phase. Photodiode-array (PDA) detection was used and quantification with MaxPlot was in the range 210–400 nm. Regression analysis revealed linear relationships between peak area and amount of each additive from 0.1 to 10 μ mL -1, with correlation coefficients between 0.9971 and 0.9983. Inter-day and intraday precision for the four preservatives at three concentrations were 0.04–0.05% for retention time and 0.81–1.29% for peak area. Recovery was from 91.4-105.8%. The method was used for analysis of parabens in cosmetics and was proved suitable for rapid and reliable quality control.

10

Computer-assisted searching for coumarins in Peucedanum alsaticum L. and Peucedanum cervaria (L.) Lap.

Skalicka-Woźniak K., Markowski W., Świeboda R., Głowniak K.

Acta Chromatographica

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2009

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Vol. 21, no. 4

531--546

EN

The objective of the work was continuation of our study on identification of target coumarins in extracts from Peucedanum alsaticum L. and Peucedanum cervaria (L.) Lap., by use of ChromSword, on the basis of relationships between retention data and descriptors such as partial molecular volume of structural fragments in water and energies of electrostatic interactions of bond dipoles with water (QSRR). The coumarins were mainly identified by comparing UV spectra from gradient runs with spectra from the literature. The presence of columbianadin, ostruthin, and 8-methoxypeucedanin in the fruits of P. cervaria (L.) Lap. and oxypeucedanin and isoimperatorin in the fruits of P. alsaticum was confirmed. The optimum conditions obtained from DryLab simulation were used for both RP-HPLC and RP-UPLC.