Identification and characterization of degradation products of dicloxacillin in bulk drug and pharmaceutical dosage forms

Raj, T. Joseph Sunder; Bharati, C.H.; Rao, K. Ranga; Rao, P. Satyanarayana; Narayan, G. K. A. S. S.; Parikh, Kalpesh

doi:10.1016/j.jpba.2006.10.004

Cited by 14 publications

(4 citation statements)

References 5 publications

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“…Molecular weight and fragmentation data are collected using LC-MS or LC-MS-MS, and further in-depth structural data is obtained using LC-NMR analysis. [70][71] Step VII: Validation of SIMs ICH guidelines Q2A and Q2B explain Validation of analytical methods. Following other factors like accuracy, precision, linearity, range, robustness, raggedness, etc., the main focus of validation at this point is on establishing the specificity and selectivity of the method.…”

Section: Step Vi: Identiûcation and Characterization Of Degradation P...mentioning

confidence: 99%

Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods

Chandramore

Sonawane

2022

Biosci., Biotech. Res. Asia

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This article provides an overview on Development and Validation of Force degradation study with Stability Indicating Methods (SIMs) for drug substances. Different stress conditions (hydrolysis, oxidation, thermal, and photolytic conditions) are applied to drugs compounds during a process known as forced degradation, and as a result, various degradation products are created. The major purpose of these investigations is to assess a molecule's stability under accelerated settings. It is well recognized that the stability of molecules affects the regulatory documentation process, the choice of appropriate storage and packaging conditions, and the choice of formulation. The deficiencies of reported methods in terms of regulatory requirements are highlighted. This article is to provide appropriate International conference of harmonization (ICH) criteria for force degradation study and to discuss the methodical process for creating verified SIAMs. The aspects of Mass balance in SIMs are discussed and technique used in SIMs were highlighted. Recent advance in stability indicating methods include characterization of degrdant sample and in-vitro toxicity prediction are addressed. Background of force degradation study with stability indicating methods with respect to international author and national author are discussed.

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Section: Step Vi: Identiûcation and Characterization Of Degradation P...mentioning

confidence: 99%

Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods

Chandramore

Sonawane

2022

Biosci., Biotech. Res. Asia

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“…The separation was achieved on a reversed-phase C 18 column using methanol-water-acetic acid (78:21.9: 18 Joseph Sunder Raj et al were studied degradation products of dicloxacillin sodium by HPLC and three impurities were detected. 19 Isolation and characterisation of impurity in Phenazopyridine HCl bulk drug was done by analytical HPLC and the impurity was identified to be 3-phenyl-5-phenylazo-pyridine-2,6-diamine. chloride, were detected by a simple isocratic reverse phase high performance liquid chromatography by Krishna Reddy and co-workers.…”

Section: High Performance Liquid Chromatography (Hplc)mentioning

confidence: 99%

Impurities in Pharmaceuticals- A Review.

.¹,

Deshmukh²,

Chaudhari³

2013

JCPR

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Impurity is defined as any substance coexisting with the original drug, such as starting material or intermediates or that is formed due to any side reactions. The impurity may be developed either during formulation, or upon aging of both API's and formulated API's in medicines. The presence of these unwanted chemicals, even in small amount, may influence the efficacy and safety of the pharmaceutical products. The control of impurities is currently a critical issue to the pharmaceutical industry. Impurity profiling includes identification, structure elucidation and quantitative determination of impurities and degradation products in bulk drug materials and pharmaceutical formulations. Identification of impurities is done by variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques. The advent of hyphenated techniques has revolutionized impurity profiling, by not only separation but structural identification of impurities. This review highlights the different types of impurities and various methods for isolation, separation and characterization of impurities.

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“…Isoxazolyl-Penicillins (IP) are a group of semisynthetic antibiotics with a nucleus of 6-aminopenicillanic acid, their structures consist of a β-lactam fused to a thiazolidine ring (Apelblat & Bešter-Rogač, 2015). IP treat infections caused by Gram-positive bacteria such as Staphylococcus aureus, Bacillus cereus, and Streptococcus pneumoniae (Cha et al, 2006;Hou & Poole, 1971;Sunder et al, 2007;Yamada & Sato, 1962). IP action focuses on the inhibition of cell wall synthesis and murein assembly (Gothwal & Shashidhar, 2015).…”

Section: Introductionmentioning

confidence: 99%

Elimination of Isoxazolyl-Penicillins antibiotics in waters by the ligninolytic native Colombian strain Leptosphaerulina sp. considerations on biodegradation process and antimicrobial activity removal

Copete-Pertuz

Plácido

Serna-Galvis

et al. 2018

Science of The Total Environment

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In this work, Leptosphaerulina sp. (a Colombian native fungus) significantly removed three Isoxazolyl-Penicillin antibiotics (IP): oxacillin (OXA, 16000 μg L), cloxacillin (CLX, 17500 μg L) and dicloxacillin (DCX, 19000 μg L) from water. The biological treatment was performed at pH 5.6, 28 °C, and 160 rpm for 15 days. The biotransformation process and lack of toxicity of the final solutions (antibacterial activity (AA) and cytotoxicity) were tested. The role of enzymes in IP removal was analysed through in vitro studies with enzymatic extracts (crude and pre-purified) from Leptosphaerulina sp., commercial enzymes and enzymatic inhibitors. Furthermore, the applicability of mycoremediation process to a complex matrix (simulated hospital wastewater) was evaluated. IP were considerably abated by the fungus, OXA was the fastest degraded (day 6), followed by CLX (day 7) and DCX (day 8). Antibiotics biodegradation was associated to laccase and versatile peroxidase action. Assays using commercial enzymes (i.e. laccase from Trametes versicolor and horseradish peroxidase) and inhibitors (EDTA, NaCl, sodium acetate, manganese (II) ions) confirmed the significant role of enzymatic transformation. Whereas, biomass sorption was not an important process in the antibiotics elimination. Evaluation of AA against Staphylococcus aureus ATCC 6538 revealed that Leptosphaerulina sp. also eliminated the AA. In addition, the cytotoxicity assay (MTT) on the HepG2 cell line demonstrated that the IP final solutions were non-toxic. Finally, Leptosphaerulina sp. eliminated OXA and its AA from synthetic hospital wastewater at 6 days. All these results evidenced the potential of Leptosphaerulina sp. mycoremediation as a novel environmentally friendly process for the removal of IP from aqueous systems.

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Identification and characterization of degradation products of dicloxacillin in bulk drug and pharmaceutical dosage forms

Cited by 14 publications

References 5 publications

Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods

Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods

Impurities in Pharmaceuticals- A Review.

Elimination of Isoxazolyl-Penicillins antibiotics in waters by the ligninolytic native Colombian strain Leptosphaerulina sp. considerations on biodegradation process and antimicrobial activity removal

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