Method Validation for Vancomycin Analysis in Extemporaneous Suspensions via HPLC
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Abstract
Introduction: The objective of this research was to validate the method for analyzing vancomycin extemporaneous suspensions with the dose of vancomycin 25 mg/mL by using high performance liquid chromatography (HPLC). The formulation of vancomycin extemporaneous suspension was developed from the formulation from Sappasitthiprasong hospital in Ubon Ratchathani. The validation method for analyzing vancomycin extemporaneous suspensions was one part of the chemical stability testing that used for finding the shelf-life and suitable storage conditions. Materials and methods: The study of method validation for vancomycin extemporaneous suspensions was included in the topics of linearity, precision, limit of detection (LOD), limit of quantitation (LOQ) and accuracy. This method validation was developed and based on ICH guideline 2005 acceptance criteria. Such method was evaluated via HPLC under the HPLC conditions with the mobile phase composition of acetonitrile : water in 15 : 85, flow rate 1 mL/min, volume of injection at 20 µL, HPLC column C18 4.6 x 250 mm containing particle size 5.0 µm. All samples were analyzed by using UV detector at the wavelength of 280 nm. Results: The r-square of linearity was more than 0.9999 with the range of the concentration 12.5-200 µg/mL. The precision results exhibited in the percentage of the relative standard deviation (%RSD) were less than 2 in both intraday and interday. From the data of analytical chemistry, the LOD and LOQ can be detected at 1.8878 µg/mL and 6.0122 µg/mL. Moreover, the accuracy data were shown in the %recovery of vancomycin in the range of 90-115%. Conclusion: The method for analyzing vancomycin extemporaneous suspensions met the general requirement for validation. It was accurate and reliable for using as a stability-indicating method for the determination of vancomycin extemporaneous suspensions.
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