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Production of Anti-Recombinant Human Insulin Antibody and Validation by Indirect ELISA Ambarsari, Christy; Suryadi, Herman; Yanuar, Arry
Indonesian Journal of Pharmaceutical Science and Technology Vol 10, No 3 (2023)
Publisher : Indonesian Journal of Pharmaceutical Science and Technology

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.24198/ijpst.v10i3.40641

Abstract

Human insulin potential has become an interest and is important in maintaining the success of therapyin patients with the availability of chemical-based analytical methods, however, only a few have beenusing immunoassays. This study aimed to produce IgG polyclonal antibodies from rabbits immunizedwith 1 mg/mL rhINS subcutaneously and validated by indirect ELISA. Antibody was precipitated andfractioned on a HiTrap® Protein A HP column before being quantified with a UV spectrophotometerat λ 280 nm. The characterization was conducted by Dot Blot test on a BCIP-NBT substrate, as well asSDS-PAGE and Western Blot with polyacrylamide gel concentrations of 7.5% and 17.5%. Validationwas performed using solutions containing glycerol and m-cresol as matrices spiked with rhINS. Thelinearity test in the rhINS concentration range of 80.11-200.28 μg/mL (r = 0.99) showed the linearresult. The accuracy and precision obtained an average of 99.11%±5.01 and 3.91%, while the LODand LOQ were 22.05 μg/mL and 73.51 μg/mL, respectively. Human insulin was stable at 2-8oC for 24hours (α: 0.05, ANOVA). In conclusion, in-house produced IgG polyclonal antibodies and goat anti-IgG peroxidase conjugate can be used for routine testing of human insulin.
Cisplatin, Chemotherapy Agent: Production of Reference Standard for Products Determination Ambarsari, Christy
Jurnal KESANS : Kesehatan dan Sains Vol 5 No 6 (2026): KESANS: International Journal of Health and Science
Publisher : Rifa'Institute

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.54543/kesans.v5i6.590

Abstract

Introduction: Cisplatin is a cytotoxic drug that is used as cancer therapy. To ensure the success of treatment, the drug products must be examined using reference standards. Objective: Cisplatin has been developed as a reference standard for the quantification of products, both pre-market and post-market. Method: The conducted tests included FTIR assays, water content analysis, impurity assay, and homogeneity evaluation. Result and Discussion: The RP-HPLC assay results demonstrated the qualified suitability, linearity, and accuracy. The homogeneity test yielded a linearity represented by the equation y = 5.668.152,75x + 411,5 (r =1). The response factor deviation indicated an accuracy of 0,23%, and homogeneity was confirmed with Fcal = 0,17 (Ftable = 3,02). Conclusions: Cisplatin can be used as a reference standard, with an assigned value of 97,15% (U = 1,43%).