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Different stability-indicating chromatographic methods for specific determination of paracetamol, dantrolene sodium, their toxic impurities and degradation products.
Biomed Chromatogr. 2019 Sep; 33(9):e4598.BC

Abstract

A well-known analgesic (paracetamol, PAR) and skeletal muscle relaxant [dantrolene sodium (DNS)] have been analyzed without interference from their toxic impurities and degradation products. The studied PAR impurities are the genotoxic and nephrotoxic p-amino phenol (PAP) and the hepatotoxic and nephrotoxic chloroacetanilide, while 5-(4-nitrophenyl)-2-furaldehyde is reported to be a mutagenic and carcinogenic degradation product of DNS. The five studied components were determined and quantified by TLC-densitometric and RP-HPLC methods. TLC-densitometry (method 1) used TLC silica gel and chloroform-ethyl acetate-acetic acid-triethylamine (7:3:0.5:0.05, by volume) as the mobile phase with UV scanning at 230 nm, while RP-HPLC (method 2) was based on separation on a C18 column using methanol-water (55:45, v/v pH 3 with aqueous formic acid) as mobile phase at 1 mL/min and detection at 230 nm. The developed methods were used for determination and quantification of the five studied components in different laboratory-prepared mixtures. The were also applied for analysis of Dantrelax® compound capsules where no interference among the studied components with each other or from excipients was observed. The methods were validated as per International Conference on Harmonization guidelines, and they compared favorably with the reported ones.

Authors+Show Affiliations

Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt. Pharmaceutical Chemistry, Faculty of Pharmacy, Nahda University, Beni-Suef, Egypt.Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt. Pharmaceutical Chemistry, Faculty of Pharmacy, Nahda University, Beni-Suef, Egypt.Pharmaceutical Chemistry, Faculty of Pharmacy, Nahda University, Beni-Suef, Egypt.Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Ain shams University, Cairo, Egypt.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31108565

Citation

Abdelwahab, Nada S., et al. "Different Stability-indicating Chromatographic Methods for Specific Determination of Paracetamol, Dantrolene Sodium, Their Toxic Impurities and Degradation Products." Biomedical Chromatography : BMC, vol. 33, no. 9, 2019, pp. e4598.
Abdelwahab NS, Abdelrahman MM, Boshra JM, et al. Different stability-indicating chromatographic methods for specific determination of paracetamol, dantrolene sodium, their toxic impurities and degradation products. Biomed Chromatogr. 2019;33(9):e4598.
Abdelwahab, N. S., Abdelrahman, M. M., Boshra, J. M., & Taha, A. A. (2019). Different stability-indicating chromatographic methods for specific determination of paracetamol, dantrolene sodium, their toxic impurities and degradation products. Biomedical Chromatography : BMC, 33(9), e4598. https://doi.org/10.1002/bmc.4598
Abdelwahab NS, et al. Different Stability-indicating Chromatographic Methods for Specific Determination of Paracetamol, Dantrolene Sodium, Their Toxic Impurities and Degradation Products. Biomed Chromatogr. 2019;33(9):e4598. PubMed PMID: 31108565.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Different stability-indicating chromatographic methods for specific determination of paracetamol, dantrolene sodium, their toxic impurities and degradation products. AU - Abdelwahab,Nada S, AU - Abdelrahman,Maha M, AU - Boshra,John M, AU - Taha,Ahmed A, Y1 - 2019/07/03/ PY - 2019/03/27/received PY - 2019/04/15/revised PY - 2019/05/09/accepted PY - 2019/5/21/pubmed PY - 2020/1/7/medline PY - 2019/5/21/entrez KW - PR-HPLC KW - TLC-densitometry KW - dantrolene sodium KW - degradation product KW - impurity KW - paracetamol SP - e4598 EP - e4598 JF - Biomedical chromatography : BMC JO - Biomed. Chromatogr. VL - 33 IS - 9 N2 - A well-known analgesic (paracetamol, PAR) and skeletal muscle relaxant [dantrolene sodium (DNS)] have been analyzed without interference from their toxic impurities and degradation products. The studied PAR impurities are the genotoxic and nephrotoxic p-amino phenol (PAP) and the hepatotoxic and nephrotoxic chloroacetanilide, while 5-(4-nitrophenyl)-2-furaldehyde is reported to be a mutagenic and carcinogenic degradation product of DNS. The five studied components were determined and quantified by TLC-densitometric and RP-HPLC methods. TLC-densitometry (method 1) used TLC silica gel and chloroform-ethyl acetate-acetic acid-triethylamine (7:3:0.5:0.05, by volume) as the mobile phase with UV scanning at 230 nm, while RP-HPLC (method 2) was based on separation on a C18 column using methanol-water (55:45, v/v pH 3 with aqueous formic acid) as mobile phase at 1 mL/min and detection at 230 nm. The developed methods were used for determination and quantification of the five studied components in different laboratory-prepared mixtures. The were also applied for analysis of Dantrelax® compound capsules where no interference among the studied components with each other or from excipients was observed. The methods were validated as per International Conference on Harmonization guidelines, and they compared favorably with the reported ones. SN - 1099-0801 UR - https://www.unboundmedicine.com/medline/citation/31108565/Different_stability_indicating_chromatographic_methods_for_specific_determination_of_paracetamol_dantrolene_sodium_their_toxic_impurities_and_degradation_products_ L2 - https://doi.org/10.1002/bmc.4598 DB - PRIME DP - Unbound Medicine ER -