title: Validation of a simple, rapid and cost effective method for the estimation of caprylic acid and sodium caprylate from biological products using NEFA-C kit.
abstract: The method for the determination of caprylic acid and sodium caprylate from biological products was systematically validated using NEFA-C kit. The results obtained demonstrated that the kit method was simple, rapid, reliable, sensitive, reproducible and cost effective in comparison to the current methods i.e. colorimetric, High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) methods. The assay exhibited excellent linearity, accuracy, precision and robustness. Mean recoveries ranged between 95 and 101.3% (n=6). The proposed method was linear over the concentration range of 0.05-10mM of caprylate with values of coefficient of regression being>0.99. Method showed sensitivity of 0.05 mM (7.21 microg/ml for caprylic acid and 8.31 microg/ml for sodium caprylate). The % Relative standard Deviation (%RSD) for intra and interprecision studies was less than 5%. In conclusion the validated method was successfully used in monitoring of processed bulk and final products generated during production of biological products thus laying emphasis on strict control of release criteria for biological products fractionated using caprylic acid.
authors.affiliation: Research and Development (Biologicals), Bharat Serums and Vaccines Ltd, DIL Complex, Near Tatwagyan Vidyapeeth, Thane (W), Maharashtra 400607, India.
authors.forename: Maithili
authors.initials: M
authors.lastname: Athavale
authors.forename: Aldon
authors.initials: A
authors.lastname: Fernandes
authors.forename: John
authors.initials: J
authors.lastname: Kaundinya
authors.forename: Gautam
authors.initials: G
authors.lastname: Daftary
mesh_terms: D001688:Biological Products / Q000737:chemistry* / Q000378:metabolism; D002210:Caprylates / Q000032:analysis* / Q000494:pharmacology; D005591:Chemical Fractionation; D002626:Chemistry, Pharmaceutical / Q000191:economics / Q000379:methods; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D003362:Cost-Benefit Analysis; D005230:Fatty Acids, Nonesterified / Q000378:metabolism / Q000494:pharmacology*; D005240:Feasibility Studies; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000191:economics; D012964:Sodium / Q000032:analysis / Q000494:pharmacology; D013997:Time Factors
chemical_list: D001688:Biological Products; D002210:Caprylates; D005230:Fatty Acids, Nonesterified; D011933:Reagent Kits, Diagnostic; D012964:Sodium; C031492:octanoic acid