Stability Indicating Reversed-Phase High Performance Liquid Chromatography Method for Determination of Impurities in Ofloxacin Tablet Formulations

Reddy, B. Venkateswara; Kumar, Avvaru Praveen; Reddy, Gosula Venkat Ram; Sahai, Mohinish; Sreeramulu, J.; Park, Jung Hag

doi:10.1080/00032711003731423

Cited by 7 publications

(1 citation statement)

References 11 publications

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“…Important information obtained regarding the impurity by comparison between three methods, two impurities were detected at a low level. It is a combination of separation and identification technique, since requiring a small volume of the sample as well as provide high resolution and sensitivity [73][74][75][76][77] .…”

Section: Capillary Zone Electrophoresis-mass Spectrometry (Cze-ms)mentioning

confidence: 99%

A Review: Recent Trends in Analytical Techniques for Characterization and Structure Elucidation of Impurities in the Drug Substances

Parmar¹,

Shaik²

2021

ijps

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Parmar et al.: Recent Analytical Techniques for Characterization of ImpuritiesImpurity is an unwanted substance present in the active pharmaceutical ingredients that form during the synthesis process of active pharmaceutical ingredients or any unwanted constituent that is produced besides the active ingredient during the formulation or the aging of active pharmaceutical ingredients. Even the insignificant quantity of impurity existing in the medicinal product may harm the patient life and compromises the purity and superiority of the medicinal product. According to International council for harmonisation guidelines, analytical monitoring of impurity is a prerequisite and mandatory requirement for approval of market authorization of the new drug substance. Any pharmaceutical product would be capable to serve their intended therapeutic activity when they are free from impurity. Thus, an impurity existing in an active pharmaceutical ingredient needs to be identified and quantify with the help of modern analytical approaches. This review explores the basic information concerning impurity profiling, highlights the advantages of an analytical technique and also focuses on the limitation of different analytical methods for impurity profiling with possible ways to overcome the limitation.

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Section: Capillary Zone Electrophoresis-mass Spectrometry (Cze-ms)mentioning

confidence: 99%

A Review: Recent Trends in Analytical Techniques for Characterization and Structure Elucidation of Impurities in the Drug Substances

Parmar¹,

Shaik²

2021

ijps

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Development and validation of a generic stability‐indicating MEEKC method for five fluoroquinolone antibiotics

2015

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In this paper, a reliable stability-indicating generic MEEKC method for the analysis of five commonly used fluoroquinolones (FQs) has been developed and optimized by a central composite circumscribed experimental design. The separation was carried out using a fused silica capillary (60.2 cm total length) and a microemulsion (ME) composed of 81.75% (w/w) of a 125 mM NaH PO solution having a pH of 2.75, 2.65% (w/w) SDS, 1.00% (w/w) n-octanol, 6.60% (w/w) n-butanol and 8.00% (w/w) 2-propanol. A voltage of 28 kV was applied in a reverse polarity mode. A linear relationship was established from 0.04 to 0.48 mg/ml with R values higher than 0.98 for all five FQs. Both repeatability and intermediate precision were less than 3% and accuracy ranging from 97 to 100%. Of note, ciprofloxacin impurity A and ofloxacin impurity A could be separated from the respective drug substance in a single run which cannot be achieved using the official HPLC method from the European Pharmacopoeia. Forced degradation of all FQs under heat, in acidic and alkaline medium, in the presence of oxidizing agents and under neutral hydrolysis conditions was investigated. The highest yield of degradation products was observed using oxidative hydrogen peroxide. Hence, the proposed MEEKC method can be used for the quantitative determination of the five FQs and their potential impurities within a total runtime of 20 min.

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Universal response method for accurate quantitative analysis of the impurities in quinolone antibiotics using liquid chromatography coupled with diode array detector and charged aerosol detector

Gao,

Wang,

Zhu

et al. 2023

Journal of Chromatography A

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Stability Indicating Reversed-Phase High Performance Liquid Chromatography Method for Determination of Impurities in Ofloxacin Tablet Formulations

Cited by 7 publications

References 11 publications

A Review: Recent Trends in Analytical Techniques for Characterization and Structure Elucidation of Impurities in the Drug Substances

A Review: Recent Trends in Analytical Techniques for Characterization and Structure Elucidation of Impurities in the Drug Substances

Development and validation of a generic stability‐indicating MEEKC method for five fluoroquinolone antibiotics

Universal response method for accurate quantitative analysis of the impurities in quinolone antibiotics using liquid chromatography coupled with diode array detector and charged aerosol detector

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