Quantitative Determination Method for Trace Amount of Penicillin Contaminants in Commercially Available Drug Product by HPLC Coupled with Tandem Mass Spectrometry

Takada, Wataru; Adachi, Toshikazu; Kihara, Noriaki; Kitamura, Satoshi; Kitagawa, Takuya; Mifune, Masaki; Saito, Yutaka

doi:10.1248/cpb.53.172

Cited by 6 publications

(1 citation statement)

References 13 publications

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“…The literature also reports methods to analyze FLU and its degradation products by HPLC [18] or RMN methods [19]. Moreover, the literature presents analytical methods to quantify flucloxacillin sodium in pharmaceutical dosage forms when it is associated with others penicillins [20][21][22][23][24][25].…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of a UV-Spectrophotometric Method for Determination of Flucloxacillin Sodium in Capsules

Fiorentino¹,

Salgado

2012

CPA

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Flucloxacillin (FLU) is a semi-synthetic penicillin active against many gram-positive bacteria such as streptococci and penicilinase-producing staphylococci, including methicillin-susceptible S. aureus. A simple, rapid, reproducible and cost-effective UV-spectrophotometric analytical method was validated to assay flucloxacillin sodium (FLU) in capsules. Measurements were taken at 274 nm using ultra-purified water as the solvent. This new method was validated in accordance with ICH requirements, which include linearity, precision, accuracy, specificity, robustness, detection and quantitation limits. The method demonstrated good linearity over the range of 50.0 to 100.0 mg L -1 FLU with a correlation coefficient (r) equal to 0.9998. The accuracy of the method was 100.09%. The precision demonstrated a relative standard deviation of less than 2.5%. The excipient in the capsules did not interfere with the assay. The results were satisfactory when compared with the literature. The proposed method might be applied in routine quality control in the pharmaceutical industries since it is precise, accurate, simple, economic and produces very low amounts of solvents and residues.

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Section: Introductionmentioning

confidence: 99%

Development and Validation of a UV-Spectrophotometric Method for Determination of Flucloxacillin Sodium in Capsules

Fiorentino¹,

Salgado

2012

CPA

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Current literature in mass spectrometry

2005

J. Mass Spectrom.

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In order to keep subscribers up‐to‐date with the latest developments in their field, John Wiley & Sons are providing a current awareness service in each issue of the journal. The bibliography contains newly published material in the field of mass spectrometry. Each bibliography is divided into 11 sections: 1 Books, Reviews & Symposia; 2 Instrumental Techniques & Methods; 3 Gas Phase Ion Chemistry; 4 Biology/Biochemistry: Amino Acids, Peptides & Proteins; Carbohydrates; Lipids; Nucleic Acids; 5 Pharmacology/Toxicology; 6 Natural Products; 7 Analysis of Organic Compounds; 8 Analysis of Inorganics/Organometallics; 9 Surface Analysis; 10 Environmental Analysis; 11 Elemental Analysis. Within each section, articles are listed in alphabetical order with respect to author (4 Weeks journals ‐ Search completed at 6th. July 2005)

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Penicillins

Marchand‐Brynaert

Brulé

2008

Comprehensive Heterocyclic Chemistry III

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Quantitative Determination Method for Trace Amount of Penicillin Contaminants in Commercially Available Drug Product by HPLC Coupled with Tandem Mass Spectrometry

Cited by 6 publications

References 13 publications

Development and Validation of a UV-Spectrophotometric Method for Determination of Flucloxacillin Sodium in Capsules

Development and Validation of a UV-Spectrophotometric Method for Determination of Flucloxacillin Sodium in Capsules

Current literature in mass spectrometry

Penicillins

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