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DEVELOPMENT AND VALIDATION OF A HIGH-PERFORMANCE LIQUID CHROMATOG-RAPHY METHOD FOR QUANTIFICATION OF MOLNUPIRAVIR
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Abstract
Abstract: The study's goal is to develop and validate a procedure for quantifying molnupiravir in pharmaceutical dosage forms using high-performance liquid chromatography (HPLC). The chromatography process was performed on a Shimadzu C18 column (250 x 4.6 mm; 5 mm), detected with a photodiode detector (PDA) at a wavelength of 235 nm. The elution process is isocratic with a mobile phase consisting of methanol: water in a ratio of 40:60, a flow rate of 1.0 mL/min. The sample is dissolved in the mobile phase. The linearity of the method is achieved in the concentration range of 0.05 - 0.25 mg/mL. The limit of detection (LOD) is 0.00053 mg/mL, the limit of quantification (LOQ) is 0.00161 mg/mL. The accuracy of the method is determined by the % recovery rate in the range of 98.3 - 100.4%. The accuracy has RSD% = 0.48%. The survey results all met the requirements for system compatibility, specificity, linearity, precision, accuracy, limit of detection (LOD) and limit of quantification (LOQ). This proposed method can be applied to determine molnupiravir content in pharmaceuticals.
Keywords: molnupiravir, high performance liquid chromatography, validation of quantitative procedures
Article Details
Keywords
molnupiravir, high performance liquid chromatography, validation of quantitative procedures
References
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