Development and Validation of a New HPLC Method for Quantification of a Novel Antifungal Drug Based on 1,3,4-Thiadiazole and its Impurities
Chromatographic behavior of a new antifungal drug, (2-[(Z)-1-(3,5-diphenyl-1,3,4-thiadiazol-2(3H)-ylidene)-methyl]-3,5-diphenyl-1,3,4-thiadiazol-3-ium chloride (TDZ), and its impurities was studied using several types of columns, mobile phases and elution modes. A new reversed phase high-performance...
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Published in | Chromatographia Vol. 82; no. 11; pp. 1633 - 1639 |
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Main Authors | , , |
Format | Journal Article |
Language | English |
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01.11.2019
Springer Nature B.V |
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Abstract | Chromatographic behavior of a new antifungal drug, (2-[(Z)-1-(3,5-diphenyl-1,3,4-thiadiazol-2(3H)-ylidene)-methyl]-3,5-diphenyl-1,3,4-thiadiazol-3-ium chloride (TDZ), and its impurities was studied using several types of columns, mobile phases and elution modes. A new reversed phase high-performance liquid chromatography (HPLC) method for the determination of TDZ and its impurities in a pharmaceutical substance and dosage form (tablets, 60 mg) was developed and validated. The optimal chromatographic separation of TDZ and its impurities was performed on a 5-μm C8 column (4.6 mm × 250 mm, I.D.). The mobile phase consisted of 0.03% TFA in water (pH 2.5) and acetonitrile under gradient elution condition (from 40:80 v/v to 80:20 v/v for 20 min) at a flow rate of 1.0 mL min
−1
. UV detection was set at a wavelength of 250 nm. The limit of detection (LOD) and quantification (LOQ) were 0.05 and 0.1 μg mL
−1
, respectively. The method showed good linearity (
r
2
> 0.999) over the assayed concentration range (0.1–1.4 μg mL
−1
for quantification of impurities and 0.005–0.013 mg mL
−1
for quantification TDZ) and demonstrated good intra- and inter-day precision and accuracy. The method was validated and successfully applied for quantitative determination of TDZ and its impurities in both the pharmaceutical substance and tablets. |
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AbstractList | Chromatographic behavior of a new antifungal drug, (2-[(Z)-1-(3,5-diphenyl-1,3,4-thiadiazol-2(3H)-ylidene)-methyl]-3,5-diphenyl-1,3,4-thiadiazol-3-ium chloride (TDZ), and its impurities was studied using several types of columns, mobile phases and elution modes. A new reversed phase high-performance liquid chromatography (HPLC) method for the determination of TDZ and its impurities in a pharmaceutical substance and dosage form (tablets, 60 mg) was developed and validated. The optimal chromatographic separation of TDZ and its impurities was performed on a 5-μm C8 column (4.6 mm × 250 mm, I.D.). The mobile phase consisted of 0.03% TFA in water (pH 2.5) and acetonitrile under gradient elution condition (from 40:80 v/v to 80:20 v/v for 20 min) at a flow rate of 1.0 mL min
−1
. UV detection was set at a wavelength of 250 nm. The limit of detection (LOD) and quantification (LOQ) were 0.05 and 0.1 μg mL
−1
, respectively. The method showed good linearity (
r
2
> 0.999) over the assayed concentration range (0.1–1.4 μg mL
−1
for quantification of impurities and 0.005–0.013 mg mL
−1
for quantification TDZ) and demonstrated good intra- and inter-day precision and accuracy. The method was validated and successfully applied for quantitative determination of TDZ and its impurities in both the pharmaceutical substance and tablets. Chromatographic behavior of a new antifungal drug, (2-[(Z)-1-(3,5-diphenyl-1,3,4-thiadiazol-2(3H)-ylidene)-methyl]-3,5-diphenyl-1,3,4-thiadiazol-3-ium chloride (TDZ), and its impurities was studied using several types of columns, mobile phases and elution modes. A new reversed phase high-performance liquid chromatography (HPLC) method for the determination of TDZ and its impurities in a pharmaceutical substance and dosage form (tablets, 60 mg) was developed and validated. The optimal chromatographic separation of TDZ and its impurities was performed on a 5-μm C8 column (4.6 mm × 250 mm, I.D.). The mobile phase consisted of 0.03% TFA in water (pH 2.5) and acetonitrile under gradient elution condition (from 40:80 v/v to 80:20 v/v for 20 min) at a flow rate of 1.0 mL min−1. UV detection was set at a wavelength of 250 nm. The limit of detection (LOD) and quantification (LOQ) were 0.05 and 0.1 μg mL−1, respectively. The method showed good linearity (r2 > 0.999) over the assayed concentration range (0.1–1.4 μg mL−1 for quantification of impurities and 0.005–0.013 mg mL−1 for quantification TDZ) and demonstrated good intra- and inter-day precision and accuracy. The method was validated and successfully applied for quantitative determination of TDZ and its impurities in both the pharmaceutical substance and tablets. |
Author | Sipkina, N. Yu Yakovlev, I. P. Polyakova, M. V. |
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Cites_doi | 10.1007/s11094-017-1630-3 10.3389/fphar.2014.00202 10.1016/j.ejmech.2004.06.007 10.1021/cr400131u 10.1002/cmdc.201200355 10.1111/cbdd.12125 10.2174/1389557515666150519104057 10.3389/fmicb.2017.00036 10.1016/j.ijantimicag.2007.07.019 10.1039/P19750001386 10.3390/molecules22111926 10.1016/j.ejmech.2010.07.023 |
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References_xml | – volume: 51 start-page: 444 issue: 6 year: 2017 ident: 3794_CR12 publication-title: Pharm Chem J doi: 10.1007/s11094-017-1630-3 contributor: fullname: AS Koshevenko – volume: 5 start-page: 202 year: 2014 ident: 3794_CR3 publication-title: Front Pharmacol doi: 10.3389/fphar.2014.00202 contributor: fullname: R Prasad – volume: 39 start-page: 793 year: 2004 ident: 3794_CR10 publication-title: Eur J Med Chem doi: 10.1016/j.ejmech.2004.06.007 contributor: fullname: N Demirbas – volume: 114 start-page: 5572 issue: 10 year: 2014 ident: 3794_CR6 publication-title: Agric Mater Chem Chem Rev doi: 10.1021/cr400131u contributor: fullname: Y Hu – volume: 8 start-page: 27 issue: 1 year: 2012 ident: 3794_CR8 publication-title: Chem Med Chem doi: 10.1002/cmdc.201200355 contributor: fullname: Y Li – volume: 81 start-page: 557 issue: 5 year: 2013 ident: 3794_CR11 publication-title: Chem Biol Drug Des doi: 10.1111/cbdd.12125 contributor: fullname: AK Jain – volume: 3 start-page: 1 year: 2015 ident: 3794_CR5 publication-title: Elife contributor: fullname: CB Ford – volume: 15 start-page: 762 issue: 9 year: 2015 ident: 3794_CR7 publication-title: Mini Rev Med Chem doi: 10.2174/1389557515666150519104057 contributor: fullname: J Matysiak – ident: 3794_CR1 doi: 10.3389/fmicb.2017.00036 – volume: 30 start-page: 487 year: 2007 ident: 3794_CR2 publication-title: Int J Antimicrob Agents doi: 10.1016/j.ijantimicag.2007.07.019 contributor: fullname: PL Shao – ident: 3794_CR14 – ident: 3794_CR15 – ident: 3794_CR16 – volume: 1 start-page: 1386 issue: 14 year: 1975 ident: 3794_CR13 publication-title: J Chem Soc Perkin Trans doi: 10.1039/P19750001386 contributor: fullname: PD Callaghan – volume: 22 start-page: 1926 issue: 11 year: 2017 ident: 3794_CR4 publication-title: Molecules doi: 10.3390/molecules22111926 contributor: fullname: K Szafrański – volume: 45 start-page: 4664 year: 2010 ident: 3794_CR9 publication-title: Eur J Med Chem doi: 10.1016/j.ejmech.2010.07.023 contributor: fullname: D Kumar |
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Snippet | Chromatographic behavior of a new antifungal drug, (2-[(Z)-1-(3,5-diphenyl-1,3,4-thiadiazol-2(3H)-ylidene)-methyl]-3,5-diphenyl-1,3,4-thiadiazol-3-ium chloride... |
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SubjectTerms | Acetonitrile Analytical Chemistry Chemistry Chemistry and Materials Science Chromatography Elution Flow velocity Fungicides High performance liquid chromatography Impurities Ions Laboratory Medicine Linearity Original Pharmaceuticals Pharmacy Proteomics Tablets Thiadiazoles |
Title | Development and Validation of a New HPLC Method for Quantification of a Novel Antifungal Drug Based on 1,3,4-Thiadiazole and its Impurities |
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