DEVELOPMENT AND VALIDATION OF A HPLC-PDA METHOD AND PRELIMINARY STABILITY STUDY OF SYNEPHRINE IN<i>Citrus aurantium L.</i>DRY EXTRACT

Kaefer, Cristina Lenhardt; Hellwig, Fernanda Macke; Reis, Rafael Henrique Dias; Viana, Carine; Malesuik, Marcelo Donadel

doi:10.5935/0100-4042.20150050

Cited by 3 publications

(3 citation statements)

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“…There are no indications that p ‐synephrine adversely affects the heart, liver, kidneys, or thyroid at doses up to 100 mg per day (Stohs et al ., ; Kaats et al ., ; Shara et al ., ; Kaats and Stohs, ), and as a consequence, there is no evidence supporting the proposed contraindications. Furthermore, studies have shown that no teratogenicity (Hansen et al ., ) or mutagenicity (Morimoto et al ., ; Kaefer, ; Deshmukh et al ., ) occurs in response to p ‐synephrine and bitter orange extracts. However, some cautionary statements regarding use of bitter orange extract and p ‐synephrine may be warranted and are subject to further discussions.…”

Section: Discussionmentioning

confidence: 99%

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Safety, Efficacy, and Mechanistic Studies Regarding Citrus aurantium (Bitter Orange) Extract and p‐Synephrine

Stohs

2017

Phytotherapy Research

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Citrus aurantium L. (bitter orange) extracts that contain p‐synephrine as the primary protoalkaloid are widely used for weight loss/weight management, sports performance, appetite control, energy, and mental focus and cognition. Questions have been raised about the safety of p‐synephrine because it has some structural similarity to ephedrine. This review focuses on current human, animal, in vitro, and mechanistic studies that address the safety, efficacy, and mechanisms of action of bitter orange extracts and p‐synephrine. Numerous studies have been conducted with respect to p‐synephrine and bitter orange extract because ephedra and ephedrine were banned from use in dietary supplements in 2004. Approximately 30 human studies indicate that p‐synephrine and bitter orange extracts do not result in cardiovascular effects and do not act as stimulants at commonly used doses. Mechanistic studies suggest that p‐synephrine exerts its effects through multiple actions, which are discussed. Because p‐synephrine exhibits greater adrenergic receptor binding in rodents than humans, data from animals cannot be directly extrapolated to humans. This review, as well as several other assessments published in recent years, has concluded that bitter orange extract and p‐synephrine are safe for use in dietary supplements and foods at the commonly used doses. Copyright © 2017 The Authors Phytotherapy Research Published by John Wiley & Sons Ltd.

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Section: Discussionmentioning

confidence: 99%

“…In another study published only in thesis form (Kaefer, ), p ‐synephrine and its forced degradation products were studied for their potential mutagenic effects. Degradation of p ‐synephrine was produced under acidic, basic, oxidative, and proteolytic conditions.…”

Section: Mutagenicity Studiesmentioning

confidence: 99%

Safety, Efficacy, and Mechanistic Studies Regarding Citrus aurantium (Bitter Orange) Extract and p‐Synephrine

Stohs

2017

Phytotherapy Research

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“…Therefore, it is important to establish an approach for detecting synephrine in feed. Many existing detection methods for synephrine have been presented, including TLC scanning , CE , GC–MS , LC , and HPLC–MS . In our study, a novel sample pretreatment method based on internal standards combined with UHPLC–MS/MS was developed to determine the level of synephrine in feeds.…”

Section: Introductionmentioning

confidence: 99%

Determination of synephrine in feeds by a novel quick, easy, cheap, effective, rugged, and safe solid‐phase extraction method combined with UHPLC–MS/MS

Song

Chai

Lou

et al. 2018

J of Separation Science

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To detect and quantify synephrine in feed, an effective analytical method based on quick, easy, cheap, effective, rugged, and safe solid-phase extraction coupled to ultra high performance liquid chromatography with tandem mass spectrometry was developed with isotopic internal standards. Pretreatment was performed using quick, easy, cheap, effective, rugged, and safe solid-phase extraction with primary secondary amine and C18 sorbent as sorbents in combination with Oasis MCX column clean-up to extract and purify feed samples. Tandem mass spectrometry detection in positive ion mode was conducted in positive multiple reaction monitoring mode in addition to the quantitative internal standard method. Two transitions of synephrine at m/z 168.1/150.0 and 168.1/135.0 were selected, and m/z 168.1/135.0 was determined as the quantification ion pair. D -Terbutaline was selected as an internal standard, for which m/z 235.1/153.0 was selected as the quantification ion pair. Good linearity was shown for synephrine in the range of 0.5-50 μg/L, and the correlation coefficient exceeded 0.999. The recoveries in three different feed samples at three spiked levels were 81.42-112.08%, and the relative standard deviations were not greater than 14.66%. The method proposed in this study was reliable and highly effective, and its sensitivity, accuracy, and precision are suitable for determining synephrine residues in feed samples.

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Development and Validation of an HPLC Analytical Method to Determine 6-Merpactopurine Concentration in Oral Suspension

Romão

Fonseca

Schindler

et al. 2022

CCHG

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Background: The 6-mercaptopurine is an active ingredient used to treat certain types of leukemia. This drug is an immunosuppressive and antineoplastic agent that belongs to the thiopurine class. In Brazil, 6-MP is currently available only in the form of 50 mg tablets, sold as Purinethol® and manufactured by Glaxo Smith Kline. The lack of the liquid formulation’s production impedes treatment, assuming that one of its advantages go through its applicability in pediatric patients, which shows the highest incidence among others. Objective: The purpose of this work was to evaluate the development and application of a reverse phase high performance liquid chromatography (HPLC) method using an Agilent 1220 Infinity® G4294B chromatograph with photodiode array detector. Methods: HPLC assays were performed on an Eclipse plus® C18 column (4.6 x 150 mm, 3.5 µm particle size) using a gradient mode mixture of acetonitrile and aqueous acetic acid solution as a mobile phase, with a flow of 1 mL.min-1 and detection at 324 nm. The method was validated by determining its selectivity, linearity, precision, accuracy, and robustness. Results: Retention time for 6-mercaptopurine was 5.12 minutes. The detector’s response was linear at concentrations from 1.6 to 2.4 µg/mL. The results of the method’s accuracy evaluation of the accuracy showed with mean recovery of the amount of substance added to the samples of between 99.88 and 100.5%. For precision, repeatability and intermediate precision were evaluated. The repeatability showed standard deviation of 0.0737. The intermediate precision was assessed on three different. For the three days of the studies, the values of the standard deviations were less than 3%, showing repeatability and intermediate precision adequate for the analytical method in question. The limit of detection was determined as 3.6 ng/mL. The limit of quantification was determined as 12 ng/mL. The chromatographic method was robust under the proposed Conclusion: The proposed method can be applied to quality control of 6-MP oral suspension to ensure that the required content is delivered to pediatric oncology patients.

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DEVELOPMENT AND VALIDATION OF A HPLC-PDA METHOD AND PRELIMINARY STABILITY STUDY OF SYNEPHRINE INCitrus aurantium L.DRY EXTRACT

Cited by 3 publications

References 0 publications

Safety, Efficacy, and Mechanistic Studies Regarding Citrus aurantium (Bitter Orange) Extract and p‐Synephrine

Safety, Efficacy, and Mechanistic Studies Regarding Citrus aurantium (Bitter Orange) Extract and p‐Synephrine

Determination of synephrine in feeds by a novel quick, easy, cheap, effective, rugged, and safe solid‐phase extraction method combined with UHPLC–MS/MS

Development and Validation of an HPLC Analytical Method to Determine 6-Merpactopurine Concentration in Oral Suspension

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