VALIDATION OF QUANTITATION ANALYTICAL PROCEDURE OF CEFMETAZOL IN POWDER FOR INJECTION BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) WITH PDA DETECTOR

Abstract

An accurate and sensitive method was developed for qualitative and quantitative analysis of Cefmetazol in powder for injection using high performance liquid chromatography (HPLC) with PDA detector. Chromatographic separation of Cefmetazol was performed on a HiQ Sil C18HS 4,6 mm (I.D) × 25 mm (L), 5 μm column, PDA detection at 214 nm. The mobile phase component was phosphoric acid buffer (pH 4,5 ± 0,1) which used for the isocratic elution with flow rate of 2 mL/min. The sample was dissolved in the mobile phase component. Quantitative results of Cefmetazol powder for injection obtained a linear concentration range of 0,1-0,5 mg/mL. The accuracy of the method was determined by the recovery rate in the range of 99,02-100,61%, responding to 0,25-0,29 mg/mL and the repeatability (in %RSD) of 0,22%. The analytical procedure met the criteria of specificity, linearity, accuracy, and precision set by the guidance of Circular 32/2018/Circulars - The Ministry of Health on regulations on registration of circulation of drugs and medicinal ingredients. This analytical procedure can be applied in routine quality control of Cefmetazol in powdered pharmaceutical formulations for injection