Development of a New HPLC Method for the Simultaneous Determination of Ticarcillin and Clavulanic Acid in Pharmaceutical Formulations

Tsou, Tai Li; Lee, Chiu Wey; Wang, Hsian-Jenn; Cheng, Ya Chung; Liu, Yu Tien; Chen, Su Hwei

doi:10.1093/jaoac/92.4.1089

Cited by 2 publications

(2 citation statements)

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“…Furthermore, sufficient studies are also available for simultaneous estimation of CVA and amoxicillin trihydrate and CVA and ticarcillin in bulk and pharmaceutical formulations using UV spectrophotometry, HPLC, and so forth. In addition, a validated HPLC method is also suggested for assessment of CFX and PCV in tablet dosage form at the same time [14,15]. However, till date, no suitable analytical methods for simultaneous determination of CFX and CVA in pediatric oral powder have been available.…”

Section: Introductionmentioning

confidence: 99%

A Validated RP-HPLC Method for Simultaneous Determination of Cefixime and Clavulanic Acid Powder in Pediatric Oral Suspension

Nepal

Panthi

Chaudhary

et al. 2022

International Journal of Analytical Chemistry

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A new reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of pediatric oral powder formulation containing cefixime (CFX) and clavulanic acid (CVA). In this research, an analytical C18 (4.6 mm × 25 cm), 5 μm column was used for chromatographic separation with a mixture of methanol and water containing disodium hydrogen phosphate in ratio of 20 : 80 v/v as the mobile phase (pH 5.5 adjusted with orthophosphoric acid) at a flow rate of 1.0 mL/min. The detecting wavelength and run time were 220 nm and 15 min, respectively. Moreover, the column temperature was maintained at 30°C. The analytical method was validated prior to meeting the conditions specified by International Conference on Harmonization (ICH) and the parameters were specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, robustness, and solution stability. The calibration curve was found to be linear between the concentration ranges of 0.024–0.036 mg/mL and 0.032–0.048 mg/mL for CFX and CVA, respectively. Furthermore, the LOD and LOQ of CFX were 0.0008 and 0.0025 μg/mL, respectively. Accordingly, LOD and LOQ of CVA were 0.0021 and 0.0065 μg/mL, respectively. The accuracy of the optimized method was examined by recovery studies and the mean recovery was observed to be 98.96% and 99.05% for CFX and CVA, respectively, at 100% spiked level. The repeatability testing for both standard and sample solutions revealed that the method is precise within the acceptable range and the %RSD of the precision was <2%. In addition, the findings of specificity, linearity, accuracy, precision, robustness, LOD, LOQ, and solution stability studies of both CFX and CVA were within the criteria of acceptable limit as well.

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Section: Introductionmentioning

confidence: 99%

A Validated RP-HPLC Method for Simultaneous Determination of Cefixime and Clavulanic Acid Powder in Pediatric Oral Suspension

Nepal

Panthi

Chaudhary

et al. 2022

International Journal of Analytical Chemistry

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“…The literature survey reveals a great number of HPLCmethods for individual quantifications of ticarcillin and of vancomycin in body fluids [13,14] and in pharmaceutical formulations [15,16]. Ticarcillin as well as vancomycin have been successfully separated from their respective synthesis impurities [17,18].…”

Section: Introductionmentioning

confidence: 99%

Liquid Chromatography–Tandem Mass Spectrometry for Simultaneous Determination of Ticarcillin and Vancomycin in Presence of Degradation Products. Application to the Chemical Stability Monitoring of Ticarcillin- Vancomycin Solutions

T¹

2014

J Chromatogr Sep Tech

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Acute bacterial conjunctivitis and their complications are commonly treated by 6 mg/mL ticarcillin and 50 mg/mL vancomycin eyes drops, formulated separately in hospitals. A rapid, selective and specific LC-tandem MS method has been developed and validated for simultaneous quantification of ticarcillin and vancomycinin solution and in presence of degradation products. Atlantis ® C18 Column T3 (250×4.6 mm I.D., 5 µm) and gradient mobile phase composed of 44 mM trifluoracetic acid/methanol allowed for good separation. Degradation products were separated on LC and detected with mass spectrometry in full scan mode. The method was suitable forthe stability study of ticarcillin-vancomycin pH 5.2 solutionsover an 8-day period storage at 5 ± 3°C and at room temperature (25 ± 2°C). The solutions remained stable up to 5 days at 5 ± 3°C. At room temperature, degradation of ticarcillin was accelerated in presence of vancomycin, while vancomycin stability was not further affected by ticarcillin. High-resolution mass spectrometry was used for the characterization of the degradation products.

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Development of a New HPLC Method for the Simultaneous Determination of Ticarcillin and Clavulanic Acid in Pharmaceutical Formulations

Cited by 2 publications

References 0 publications

A Validated RP-HPLC Method for Simultaneous Determination of Cefixime and Clavulanic Acid Powder in Pediatric Oral Suspension

A Validated RP-HPLC Method for Simultaneous Determination of Cefixime and Clavulanic Acid Powder in Pediatric Oral Suspension

Liquid Chromatography–Tandem Mass Spectrometry for Simultaneous Determination of Ticarcillin and Vancomycin in Presence of Degradation Products. Application to the Chemical Stability Monitoring of Ticarcillin- Vancomycin Solutions

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