Quantification of ceftriaxone sodium in pharmaceutical preparations by a new validated microbiological bioassay

Dafale, Nishant A.; Semwal, Uttam P.; Agarwal, Piyush K.; Sharma, Pradeep; Singh, Gurpreet

doi:10.1039/c2ay25145k

Cited by 23 publications

(20 citation statements)

References 18 publications

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“…The application of microbiological assay has been recently developed for intravenously administered antibiotics. This method is highly acceptable by regulating authorities to control antibiotic potency [17] , [18] . Microbiological bioassay plays an essential role in the manufacturing and quality control of antibiotic medicines and demands considerable skill and expertise to assure success [18] , [19] .…”

Section: Introductionmentioning

confidence: 99%

“…This method is highly acceptable by regulating authorities to control antibiotic potency [17] , [18] . Microbiological bioassay plays an essential role in the manufacturing and quality control of antibiotic medicines and demands considerable skill and expertise to assure success [18] , [19] . Microbiological assay helps in estimating active constituents, biological activity and in monitoring the stability of antibiotics.…”

Section: Introductionmentioning

confidence: 99%

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Development and validation of microbial bioassay for quantification of Levofloxacin in pharmaceutical preparations

Dafale

Semwal

Agarwal

et al. 2015

Journal of Pharmaceutical Analysis

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The aim of this study was to develop and validate a simple, sensitive, precise and cost-effective one-level agar diffusion (5+1) bioassay for estimation of potency and bioactivity of Levofloxacin in pharmaceutical preparation which has not yet been reported in any pharmacopoeia. Among 16 microbial strains, Bacillus pumilus ATCC-14884 was selected as the most significant strain against Levofloxacin. Bioassay was optimized by investigating several factors such as buffer pH, inoculums concentration and reference standard concentration. Identification of Levofloxacin in commercial sample Levoflox tablet was done by FTIR spectroscopy. Mean potency recovery value for Levofloxacin in Levoflox tablet was estimated as 100.90%. A validated bioassay method showed linearity (r2=0.988), precision (Interday RSD=1.05%, between analyst RSD=1.02%) and accuracy (101.23%, RSD=0.72%). Bioassay was correlated with HPLC using same sample and estimated potencies were 100.90% and 99.37%, respectively. Results show that bioassay is a suitable method for estimation of potency and bioactivity of Levofloxacin pharmaceutical preparations.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Development and validation of microbial bioassay for quantification of Levofloxacin in pharmaceutical preparations

Dafale

Semwal

Agarwal

et al. 2015

Journal of Pharmaceutical Analysis

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“…The agar diffusion method relates the size of the inhibition zone and the dose of the antibiotic assayed. The relation of the diameter of inhibitory zones and the concentration of antibiotic in a solution applied in cups has been considered theoretically [1] .…”

Section: Microbiological Assay Methodsmentioning

confidence: 99%

“…Antibiotics are drugs preparations which contain some chemical substances that are produced by microorganisms and by chemical synthesis. These substances at very low concentrations are known to totally destroy or partially inhibit microorganisms [1] , [2] . Antibiotics have widespread application in the treatment of bacterial disease [3] .…”

Section: Introductionmentioning

confidence: 99%

Selection of appropriate analytical tools to determine the potency and bioactivity of antibiotics and antibiotic resistance

Dafale

Semwal

Rajput

et al. 2016

Journal of Pharmaceutical Analysis

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Antibiotics are the chemotherapeutic agents that kill or inhibit the pathogenic microorganisms. Resistance of microorganism to antibiotics is a growing problem around the world due to indiscriminate and irrational use of antibiotics. In order to overcome the resistance problem and to safely use antibiotics, the correct measurement of potency and bioactivity of antibiotics is essential. Microbiological assay and high performance liquid chromatography (HPLC) method are used to quantify the potency of antibiotics. HPLC method is commonly used for the quantification of potency of antibiotics, but unable to determine the bioactivity; whereas microbiological assay estimates both potency and bioactivity of antibiotics. Additionally, bioassay is used to estimate the effective dose against antibiotic resistant microbes.Simultaneously, microbiological assay addresses the several parameters such as minimal inhibitory concentration (MIC), minimum bactericidal concentration (MBC), mutation prevention concentration (MPC) and critical concentration (Ccr) which are used to describe the potency in a more informative way. Microbiological assay is a simple, sensitive, precise and cost effective method which gives reproducible results similar to HPLC. However, the HPLC cannot be a complete substitute for microbiological assay and both methods have their own significance to obtain more realistic and precise results.

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“…A thorough literature survey has revealed that HPLC method for ceftriaxone sodium with combination of other drugs and individually in dosage forms [2–15], microbial bioassay methods [16, 17], and spectrophotometric methods in dosage forms [18–22] have been reported for analysis of ceftriaxone sodium. Costlier and volatile solvents were used as mobile phase solvent system and the time of analysis was more in some reported methods.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Stability Indicating Spectroscopic Method for Content Analysis of Ceftriaxone Sodium in Pharmaceuticals

Ethiraj¹,

Thiruvengadam

Sampath³

et al. 2014

International Scholarly Research Notices

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A simple, selective, and stability indicating spectroscopic method has been selected and validated for the assay of ceftriaxone sodium in the powder for injection dosage forms. Proposed method is based on the measurement of absorbance of ceftriaxone sodium in aqueous medium at 241 nm. The method obeys Beer's law in the range of 5–50 μg/mL with correlation coefficient of 0.9983. Apparent molar absorptivity and Sandell's sensitivity were found to be 2.046 × 103 L mol−1 cm−1 and 0.02732 μg/cm2/0.001 absorbance units. This study indicated that ceftriaxone sodium was degraded in acid medium and also underwent oxidative degradation. Percent relative standard deviation associated with all the validation parameters was less than 2, showing compliance with acceptance criteria of Q2 (R1), International Conference on Harmonization (2005) guidelines. Then the proposed method was successfully applied to the determination of ceftriaxone sodium in sterile preparation and results were comparable with reported methods.

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Quantification of ceftriaxone sodium in pharmaceutical preparations by a new validated microbiological bioassay

Cited by 23 publications

References 18 publications

Development and validation of microbial bioassay for quantification of Levofloxacin in pharmaceutical preparations

Development and validation of microbial bioassay for quantification of Levofloxacin in pharmaceutical preparations

Selection of appropriate analytical tools to determine the potency and bioactivity of antibiotics and antibiotic resistance

Development and Validation of Stability Indicating Spectroscopic Method for Content Analysis of Ceftriaxone Sodium in Pharmaceuticals

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