Stability indicating spectrophotometric and spectrodensitometric methods for the determination of diatrizoate sodium in presence of its degradation product

El-Rahman, Mohamed K. Abd; Riad, S.; Gawad, Sherif A. Abdel; Fawaz, Esraa M.; Shehata, Mohamed

doi:10.1016/j.saa.2014.10.002

Cited by 11 publications

(4 citation statements)

References 14 publications

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“…The release of DTA is measured by an ultraviolet spectrophotometer (UV-2700, Shimadzu Co., Ltd, Japan). Compared with high performance liquid chromatography (HPLC), 17 inductively coupled plasma mass spectrometry (ICP-MS), 34 and TLC-Densitometric method, 35 this method is simple, rapid, and low-cost, which does not need to process the sample. Figure 1(a) shows the DTA standard curve.…”

Section: Resultsmentioning

confidence: 99%

Modification and evaluation of diatrizoate sodium containing polymethyl methacrylate bone cement

et al. 2023

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Polymethyl methacrylate (PMMA) bone cement is now widely used in percutaneous vertebro plasty (PVP) and percutaneous kyphoplasty (PKP). However, studies showed that the radiopacifiers (zirconia, barium sulfate, etc.) added to PMMA will have a negative impact on its use, e.g. barium sulfate will weaken the mechanical properties of bone cement and lead to bone absorption and aseptic loosening. Iodine is an element existing in the human body and has good imaging performance. Iodine contrast agent has been used in clinic for many years and has abundant clinical data. Therefore, using iodine instead of barium sulfate may be a promising choice. In this paper, the effect of different content of diatrizoate sodium (DTA, C11H8I3N2NaO4) on the properties of PMMA was studied and compared with the traditional PMMA bone cement containing 30 wt% barium sulfate. The mechanical properties, setting properties, radiopacity, and biocompatibility of bone cement were evaluated. The compressive strength of PMMA bone cement with 20 wt% DTA can reach 76.38 MPa. DTA released from bone cement up to 14 days accounted for only 2.3% of its dosage. The water contact angle was 62.3°. The contrast of bone cement on X-ray film was comparable to that of bone cement containing 30 wt% barium. The hemolysis rate was lower than 4%, and there was no obvious hemolysis. PMMA with 20 wt% DTA can maintain the relative growth rate of MC3T3-E1 and L929 cells above 80%. The results show that adding 20 wt% DTA into PMMA can obtain good radiopacity while maintaining its mechanical properties, setting properties, and biocompatibility. DTA can be used as a promising candidate material for PMMA bone cement radiopacifier.

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Section: Resultsmentioning

confidence: 99%

Modification and evaluation of diatrizoate sodium containing polymethyl methacrylate bone cement

et al. 2023

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“…The structure of the degradate was elucidated by mass and IR spectrometry in our recently published work (Abd El‐Rahman et al ) The focus of the present study is to develop an accurate, specific, reproducible and sensitive RP‐HPLC stability‐indicating method for the determination of DTA in pure form and pharmaceutical formulation and in the presence of its acidic degradation product, and to monitor the degradation kinetics.…”

Section: Resultsmentioning

confidence: 99%

“…A review of the available literature indicated that no stability‐indicating HPLC method for the determination of DTA in the presence of its free amino degradant has previously been published in spite of its high toxicity. There are two spectrophotometric methods and a TLC‐spectrodensitometric method (Abd El‐Rahman, Riad, Gawad, Fawaz, & Shehata ). Also, there is one direct UV spectrophotometric method (Tan & Qisu, ) and another H 1 NMR method (Hanna & Lau‐Cam ) for the determination of DTA as a single component, DTA was also determined in the presence of its diiodo degradates by capillary electrophoresis technique (Farag & Wells, ) and liquid chromatography (Chellquist, Nelson, & Storflor, ).…”

Section: Introductionmentioning

confidence: 99%

Monitoring of the degradation kinetics of diatrizoate sodium to its cytotoxic degradant using a stability‐indicating high‐performance liquid chromatographic method

Fawaz

El-Rahman

Riad

et al. 2016

Biomedical Chromatography

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The X-ray diagnostic agent sodium diatrizoate (DTA) was studied for chemical degradation. The 3,5-diamino derivative was found to be the alkaline and acidic degradation product. The 3,5-diamino degradate is also the synthetic precursor of DTA and it is proved to have cytotoxic and mutagenic effects. A sensitive, selective and precise high-performance liquid chromatographic stability-indicating method for the determination of DTA in the presence of its acidic degradation product and in pharmaceutical formulation was developed and validated. Owing to the high toxicity of the degradation product, the kinetics of the acidic degradation process was monitored by the developed RP-HPLC method. The reaction was found to follow pseudo-first order kinetics. The kinetic parameters such as rate constant (K) and half-life (t ) were calculated under different temperatures and acid concentrations; activation energy was estimated from the Arrhenius plot. The developed RP-HPLC method depends on isocratic elution of a mobile phase composed of methanol-water (25:75 v/v; pH adjusted with phosphoric acid), and UV detection at 238 nm. The method showed good linearity over a concentration range of 2-100 μg/mL with mean percentage recovery of 100.04 ± 1.07. The selectivity of the proposed method was tested using laboratory-prepared mixtures. The proposed method has been successfully applied to the analysis of DTA in pharmaceutical dosage forms without interference from other dosage form additives and the results were statistically compared with the official USP method. Validation of the proposed method was performed according to International Conference on Harmonization guidelines.

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“…The induced acidic degradation was evaluated by TLC plates, the structure of the degradation product was elucidated by IR and mass spectrometry. 16 Pharmaceutical formulation.-Gastrografin solution manufactured by Schering Company (Belimed, Spain). Batch no.51424A labeled to contain 0.6 g/mL of diatrizoate anhydrous base.…”

Section: Samplesmentioning

confidence: 99%

Screen Printed Ion Selective Electrodes as a Fully Integrated PAT Tool: Application to the Analysis and Impurity Profiling of Diatrizoate Sodium

Fawaz¹,

El-Rahman²,

Riad³

et al. 2018

J. Electrochem. Soc.

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Conventional pharmaceutical manufacturing is generally accomplished via batch processing followed by laboratory testing conducted on some representative samples collected to evaluate batch quality. However, today significant opportunities exist for improving pharmaceutical quality assurance through innovation in process development and analysis. FDA's guidance for pharmaceutical industry has defined Process Analytical Technology (PAT) as a system for designing, analyzing, and controlling manufacturing through timely measurements, with the goal of ensuring final product quality. Nevertheless, pharmaceutical companies are encouraged to develop and implement innovative PAT tools for designing, analyzing, and controlling manufacturing through real-time strategies (i.e., during processing) of critical quality attributes of raw and final product. The goal of PAT is that quality cannot be tested into products; it should be built-in or should be by design. Furthermore, FDA stated that sensor-based measurements could pave the way to built-in product quality assurance which is the key to PAT development. From this perspective, this scientific approach presents screen-printed ISEs (SPEs) as a potential real-time analyzer and PAT-tool. Diatrizoate sodium (DTA) was chosen as a model analyte, it is a widely used X-ray contrast agent that is susceptible to degradation into a cytotoxic and mutagenic compound, that can be also used as its precursor. Two SPEs were fabricated and used successfully in the analysis of both DTA and its potential impurity. The proposed SPEs have the advantage of being real-time analyzers that could be fully integrated into the production cycle giving a key to a promising competent PAT-tool.

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Stability indicating spectrophotometric and spectrodensitometric methods for the determination of diatrizoate sodium in presence of its degradation product

Cited by 11 publications

References 14 publications

Modification and evaluation of diatrizoate sodium containing polymethyl methacrylate bone cement

Modification and evaluation of diatrizoate sodium containing polymethyl methacrylate bone cement

Monitoring of the degradation kinetics of diatrizoate sodium to its cytotoxic degradant using a stability‐indicating high‐performance liquid chromatographic method

Screen Printed Ion Selective Electrodes as a Fully Integrated PAT Tool: Application to the Analysis and Impurity Profiling of Diatrizoate Sodium

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