Analytical Method Validation

Booth, Brian; Simon, Witold

doi:10.1201/9780203026427-15

Cited by 26 publications

(11 citation statements)

References 4 publications

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“…Prior to analysis, it was necessary to carry out dilutions to ensure that the analyte concentration examined was within the range of the calibration curve. Furthermore, 200 µL of each diluted solution was then analyzed using high-performance liquid chromatography (HPLC) with a method that has been validated based on the standards set by the European Medicines Agency (EMA) and Food and Drug Administration (FDA) [ 30 , 31 ], which is explained in Section 2.2.10 .…”

Section: Methodsmentioning

confidence: 99%

“…with 5 µm particle size) with a UV detector set at 230 nm, and the mobile phase used was phosphate-buffer-acetonitrile (74:26) pH 4.5, flow rate was 0.8 mL/min, and column temperature of 25 °C. This chromatographic condition was referring to a previous study that has been optimized and validated as per the Food and Drug Administration (FDA) and European Medicine Agency (EMEA) bioanalytical method validation guidelines [ 30 , 31 , 34 ].…”

Section: Methodsmentioning

confidence: 99%

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Enhancing Intradermal Delivery of Lidocaine by Dissolving Microneedles: Comparison between Hyaluronic Acid and Poly(Vinyl Pyrrolidone) Backbone Polymers

et al. 2023

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Lidocaine hydrochloride (LiH), an amide-type local anesthetic agent, is commonly used in dermatological procedures. LiH is categorized as a BCS (biopharmaceutics classification system) class III group, which has high solubility and poor permeability. It should be noted that, in this context, LiH is intended as a local anesthetic, so the level of LiH in systemic circulation should be minimized to avoid toxicity and unwanted side effects such as hypotension and bradycardia. This study aimed to formulate and evaluate LiH-loaded dissolving microneedles (DMNs) with different polymer bases. Moreover, an in vitro permeation study using Franz diffusion cells and in vivo study were also performed. LiH-loaded DMNs were prepared using polymer groups of poly (vinyl pyrrolidone) (PVP-K30) and hyaluronic acid (HA). DMNs were created using the micro-molding method with centrifugation. The formulations selected based on the evaluation were F3 (HA 10%) and F5 (PVP-K30 25%). Based on the in vitro permeation study, the amount of drug permeated and deposited in the skin at F3 (HA 10%) was 247.1 ± 41.85 and 98.35 ± 12.86 μg, respectively. On the other hand, the amount of drug permeated and deposited in the skin at F5 (PVP-K30 25%) was 277.7 ± 55.88 and 59.46 ± 9.25 μg, respectively. Our in vivo drug-permeation study showed that only one rat from the PVP-K30 polymer group—with a concentration of 150.32 ng/mL—was detected on rat plasma. Therefore, LiH can be formulated into a DMN and can be deposited in the skin with a safe concentration of the drug permeating into systemic circulation.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Enhancing Intradermal Delivery of Lidocaine by Dissolving Microneedles: Comparison between Hyaluronic Acid and Poly(Vinyl Pyrrolidone) Backbone Polymers

et al. 2023

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“…In short, no carry-over was observed LOQ was 0.05 µM and linearity was confirmed up to 10 µM. Precision and accuracy were assessed within and between runs and passed the FDA requirements for analytical method development 21 . So, this method is validated to measure balenine accurately.…”

Section: Discussionmentioning

confidence: 99%

“…This method was validated on three separate days according to the US FDA guidelines for bio-analytical method validation 21 . The following parameters were considered: selectivity, linearity, within-and between-run precision and accuracy, and carryover effect.…”

Section: Uhplc-ms/ms Methods Validation For the Quantification Of Bal...mentioning

confidence: 99%

Acute balenine supplementation in humans as a natural carnosinase-resistant alternative to carnosine

Jager

Vermeulen

Baere

et al. 2023

Sci Rep

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Balenine possesses some of carnosine’s and anserine’s functions, yet it appears more resistant to the hydrolysing CN1 enzyme. The aim of this study was to elucidate the stability of balenine in the systemic circulation and its bioavailability in humans following acute supplementation. Two experiments were conducted in which (in vitro) carnosine, anserine and balenine were added to plasma to compare degradation profiles and (in vivo) three increasing doses (1–4–10 mg/kg) of balenine were acutely administered to 6 human volunteers. Half-life of balenine (34.9 ± 14.6 min) was respectively 29.1 and 16.3 times longer than that of carnosine (1.20 ± 0.36 min, p = 0.0044) and anserine (2.14 ± 0.58 min, p = 0.0044). In vivo, 10 mg/kg of balenine elicited a peak plasma concentration (Cmax) of 28 µM, which was 4 and 18 times higher than with 4 (p = 0.0034) and 1 mg/kg (p = 0.0017), respectively. CN1 activity showed strong negative correlations with half-life (ρ = − 0.829; p = 0.0583), Cmax (r = − 0.938; p = 0.0372) and incremental area under the curve (r = − 0.825; p = 0.0433). Overall, balenine seems more resistant to CN1 hydrolysis resulting in better in vivo bioavailability, yet its degradation remains dependent on enzyme activity. Although a similar functionality as carnosine and anserine remains to be demonstrated, opportunities arise for balenine as nutraceutical or ergogenic aid.

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“…The most intense transition was used for the quantitation (quantifier transition). The method was validated according to the guidelines of the FDA [ 24 ], including linearity range, limit of quantitation, limit of detection, repeatability, and extraction recovery for NG and HG media, separately ( Supplementary Material S2 ).…”

Section: Methodsmentioning

confidence: 99%

Urolithins Modulate the Viability, Autophagy, Apoptosis, and Nephrin Turnover in Podocytes Exposed to High Glucose

Kotewicz

Krauze-Baranowska

Daca

et al. 2022

Cells

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Urolithins are bioactive compounds generated in human and animal intestines because of the bacterial metabolism of dietary ellagitannins (and their constituent, ellagic acid). Due to their multidirectional effects, including anti-inflammatory, antioxidant, anti-cancer, neuroprotective, and antiglycative properties, urolithins are potential novel therapeutic agents. In this study, while considering the future possibility of using urolithins to improve podocyte function in diabetes, we assessed the results of exposing mouse podocytes cultured in normal (NG, 5.5 mM) and high (HG, 25 mM) glucose concentrations to urolithin A (UA) and urolithin B (UB). Podocytes metabolized UA to form glucuronides in a time-dependent manner; however, in HG conditions, the metabolism was lower than in NG conditions. In HG milieu, UA improved podocyte viability more efficiently than UB and reduced the reactive oxygen species level. Both types of urolithins showed cytotoxic activity at high (100 µM) concentration. The UA upregulated total and surface nephrin expression, which was paralleled by enhanced nephrin internalization. Regulation of nephrin turnover was independent of ambient glucose concentration. We conclude that UA affects podocytes in different metabolic and functional aspects. With respect to its pro-survival effects in HG-induced toxicity, UA could be considered as a potent therapeutic candidate against diabetic podocytopathy.

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Analytical Method Validation

Cited by 26 publications

References 4 publications

Enhancing Intradermal Delivery of Lidocaine by Dissolving Microneedles: Comparison between Hyaluronic Acid and Poly(Vinyl Pyrrolidone) Backbone Polymers

Enhancing Intradermal Delivery of Lidocaine by Dissolving Microneedles: Comparison between Hyaluronic Acid and Poly(Vinyl Pyrrolidone) Backbone Polymers

Acute balenine supplementation in humans as a natural carnosinase-resistant alternative to carnosine

Urolithins Modulate the Viability, Autophagy, Apoptosis, and Nephrin Turnover in Podocytes Exposed to High Glucose

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