A Novel RP-HPLC Method for Estimating Fulvestrant, Benzoyl Alcohol, and Benzyl Benzoate in Injection Formulation  

作　　者：Arjuna Rao Nekkalapudi Venu Gopal Veldi Sreenivas Pippalla Arjuna Rao Nekkalapudi;Venu Gopal Veldi;Sreenivas Pippalla(Career Point University, CP Tower 1, IPIA, Kota, Rajasthan, India;HTS Bio Pharma, Aleap Industries Estate, Pragathi Nagar, Telangana, India;Sikkim Professional University, Gangtok, India)

机构地区：[1]Career Point University, CP Tower 1, IPIA, Kota, Rajasthan, India [2]HTS Bio Pharma, Aleap Industries Estate, Pragathi Nagar, Telangana, India [3]Sikkim Professional University, Gangtok, India

出　　处：《American Journal of Analytical Chemistry》2022年第7期229-240,共12页美国分析化学（英文）

摘　　要：For the quantitative determination of Fulvestrant, Benzyl alcohol, and Benzyl benzoate in Fulvestrant injection, an original RP-HPLC approach was developed. The gradient method was developed using HPLC and a Phenomenex Luna C8, 150 × 4.6 mm, i.d 3.0 μm particle size column with a gradient programme of mobile phases A and B. With a flow rate of 1.5 mL/minute, injection volume of 10 μL, and column temperature of 35°C, UV wavelength detection at 254 nm for Benzyl alcohol and Benzoyl Benzoate and 280 nm for Fulvestrant, mobile phase-A consists of DI water and mobile phase-B consists of Acetonitrile. The current study describes a single HPLC method for developing a Fulvestrant (Active), Benzyl alcohol (Cosolvent), and Benzyl Benzoate (Cosolvent) assay for Fulvestrant injection. The assay method was determined to be suitable for quantifying three components in the pharmaceutical product and was verified according to ICH guidelines.For the quantitative determination of Fulvestrant, Benzyl alcohol, and Benzyl benzoate in Fulvestrant injection, an original RP-HPLC approach was developed. The gradient method was developed using HPLC and a Phenomenex Luna C8, 150 × 4.6 mm, i.d 3.0 μm particle size column with a gradient programme of mobile phases A and B. With a flow rate of 1.5 mL/minute, injection volume of 10 μL, and column temperature of 35°C, UV wavelength detection at 254 nm for Benzyl alcohol and Benzoyl Benzoate and 280 nm for Fulvestrant, mobile phase-A consists of DI water and mobile phase-B consists of Acetonitrile. The current study describes a single HPLC method for developing a Fulvestrant (Active), Benzyl alcohol (Cosolvent), and Benzyl Benzoate (Cosolvent) assay for Fulvestrant injection. The assay method was determined to be suitable for quantifying three components in the pharmaceutical product and was verified according to ICH guidelines.

关 键 词：FULVESTRANT Injection Formulation HPLC ASSAY Benzyl Alcohol and Benzyl Benzoate 

分 类 号：O62[理学—有机化学]