International Journal of Drug Delivery Technology
Volume 15, Issue 2

Migration of Leachables Amount of Antioxidants and Vulcanizers: Analytical Method Development and Validation for Antineoplastic Drug Injection by HPLC

Gorre Vijaya Chandra, Lakshmi Bavisetti*, V D N Kumar Abbaraju

Department of Chemistry, GSS, GITAM (Deemed to be) University, Visakhapatnam, AP, 530045, India 

Received: 8th Jan, 2025; Revised: 12th May, 2025; Accepted: 6th Jun, 2025; Available Online: 25th Jun, 2025 

ABSTRACT

An HPLC method for the analysis of leachables amounts of Antioxidants and vulcanizers was developed and validated. The method was developed and validated for quantitation on six targeted Antioxidants and vulcanizers in rubber stoppers of antineoplastic Drug Injection. Methods: The analytical method used to determine the leachableamount of antioxidants (BHT,Antioxidant 1010, Antioxidant 1330, Antioxidant 1076, Antioxidant 168) and vulcanizer(Sulfur) in packaging materials for Melphalan Hydrochloride as Injection 50mg/vial and sterile diluent to Melphalan as Injection 10.00mg/vial by HPLC method. The validation was performed on YMC-Pack ODS-AQ (4.6mm×100 mm, 3μm) chromatographic column at 30 °C, and wavelength is 225nm. Mobile phase A is methanol (100%) and Mobile Phase B is purified water at a rate of flow as 1.50mL/min, and the volume injected as 20.00μL. Gradient was set as 0min 25% and 75%, 2min 25% and 75%,4min 100% and 0%,7min 100% and 0%,9min 25% and 75%,12min 25% and 75%. Results: The validation results of Leachables amount of antioxidants(BHT, Antioxidant 1010, Antioxidant 1330, Antioxidant 1076, Antioxidant 168) and vulcanizer (Sulfur) were linear over the concentration from 0.99 µg/mL to 8.078µg/mL (r = 0. 99) and the recoveries and precision ranged from 96.8% to 100.8% (RSD <10%, n =6). Conclusion:This method has been developed and validated successfully and all the results met the acceptance criteria. Hence this method is suitable for testing of Migration of Antioxidants and vulcanizer Melphalan Hydrochloride as Injection 50.00mg/vial along with sterile diluent for Melphalan as Injection 10mg/vial.

Keywords: Leachables, Migration, HPLC, Antioxidants, Vulcanizer, BHT,Sulfur, Packaging materials,Injection, and AET

How to cite this article: Gorre Vijaya Chandra, Lakshmi Bavisetti, V D N Kumar Abbaraju. Migration of Leachables amount of Antioxidants and Vulcanizers: Analytical Method Development and Validation for Antineoplastic Drug Injection by HPLC. International Journal of Drug Delivery Technology. 2025;15(2): 671-79. doi:10.25258/ijddt.15.2.38

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