International Journal of Drug Delivery Technology
Volume 15, Issue 2

Utilization of Becalutamide Pertinent to Antiandrogen for Development and Validation - A New Perspective 

Nagendrababu RAV1, Andrews BSA1*, V D N Kumar Abbaraju1, Garimi Tirumala Jyothesh Kumar2, K Nagu3 

1,3Department of Chemistry, GSS, GITAM University, Andhra Pradesh, Visakhapatnam (530045), India

2IPDO, Dr. Reddy's Laboratories, Bachupally, Hyderabad (500090), India

3Aditya Degree and PG College(A), Kakinada, Andhra Pradesh (533001), India 

Received: 8th Jan, 2025; Revised: 13th Mar, 2025; Accepted: 7th May, 2025; Available Online: 25th June, 2025 

ABSTRACT

A new validated HPLC process is developed to determine Bicalutamide (BIC) in pharma formulation. For this analysis Hypersil ODS C18 100 mm × 4.0 mm, 3µ Column, or equivalent is used as a chromatographic column.  Isocratic elution is observed at 1.00ml/min. Water as 70v/v, tetrahydrofuran as 20v/v, and acetonitrile as 10v/v of were used as a mobile phase. Run time was identified at 0.50mL/min to 1.50mL/min.  225nm is the UV detection wavelength.  4.0μl sample is injected into the column.   For the Sample, blank, placebo, system suitability run time is measured at a time interval of 16 minutes, and for the diluted regular sample it is 60minutes. ± 2.4 minutes is the approximate retention time is identified to BIC. % R.S.D is calculated. For this drug mean percentage recovery is within the limit. By considering the values obtained, this prospective HPLC is successfully applied to formulations. The waste materials obtained in this process may associates with the environment without intervention, the problems ripple to both the ecosystems as well as communities, which may causes severe environmental and health risks.   By considering the environmental concerns the waste products so obtained are subjected to Biological treatment (land farming) to control the hazardous waste if any, regated the both halogenated as well as non-halogenated solvents.  This developed process is more simple also is exceptional to that of unalike mechanism which can be used in dose forms of syrup.

Keywords: RP-HPLC Refractive index detector, BIC, Rate of flow, USP reference.

How to cite this article: Nagendrababu RAV, Andrews BSA, V D N Kumar Abbaraju, Garimi Tirumala Jyothesh Kumar, K Nagu. Utilization of Becalutamide Pertinent to Antiandrogen for Development and Validation - A New Perspective. International Journal of Drug Delivery Technology. 2025;15(2): 714-20. doi:10.25258/ijddt.15.2.45

REFERENCES

  1. S M Singh, S Gauthier, F Labrie. Androgen receptor antagonists (antiandrogens): structure-activity relationships. Current Medicinal Chemistry.  2000; 7(2): 211-47. DOI:2174/0929867003375371
  2. Yen and Jaffe. Reproductive Endocrinology: Physiology, Pathophysiology, and Clinical Management. Elsevier Health Sciences. 2013; ISBN:9780323810081:688.  https://shop.elsevier.com/books/yen-and-jaffes-reproductive-endocrinology/strauss/978-0-323-81007-4
  3. Marcus, D. Feldman, D. Nelson, CJ. Rosen. Osteoporosis. 2007; 3rd Edition. Academic Press. pp. 1354. ISBN 978-0-08-055347-4. https://shop.elsevier.com/books/osteoporosis/marcus/978-0-12-370544-0
  4. Mahler, J. Verhelst, L. Denis. Clinical pharmacokinetics of the anti androgens and their efficacy in prostate cancer.  Clinical Pharmacokinetics. 1998; 34(5): 405.  https://doi.org/10.2165/00003088-199834050-00005
  5. Cockshott. Bicalutamide: clinical pharmacokinetics and metabolism. Clinical Pharmacokinetics.  2004; 43(13): 855-878. DOI: https://doi.org/10.2165/00003088-200443130-00003
  6. "Bicalutamide". The American Society of Health-System Pharmacists. Archived from the original on 29 December 2016. Retrieved 8 December2016.
  7. K, Keam S.J.  Bicalutamide 150mg. Drugs, 2006; 66 ,837, Doi https://doi.org/10.2165/00003495-200666060-00007
  8. "Casodex- bicalutamide tablet". Daily Med. 1 September 2019. Retrieved 7 May2020.
  9. V.S.S. Raman Nanduri,V.S.S. Prasad Adapa, Ratnakar Reddy Kura. Development and Validation of Stability-Indicating HPLC and UPLC Methods for the Determination of Bicalutamide. Journal of Chromatographic Science. 2012; 50(4); 316–323.  https://doi.org/10.1093/chromsci/bms010
  10. Arya,K. Kiran,A. Singh, H. Ahmad, A. Satish, K. Renuka, M. Naresh, D. Anil Kumar. Validation of RP-HPLC Method for Simultaneous Quantification of Bicalutamide and Hesperetin in Polycaprolactone-Bicalutamide-Hesperetin-Chitosan Nanoparticles. Journal of Chromatographic Science.  2015; 53: 1485. https://doi.org/10.1093/chromsci/bmv042
  11. Nageswara Rao, A.Narasa Raju, D. Nagaraju. An improved and validated LC method for resolution of bicalutamide enantiomers using amylose tris-(3,5-dimethylphenylcarbamate) as a chiral stationary phase. Journal of Pharmaceutical and Biomedical Analysis. 2006; 42: 347. https://doi.org/10.1016/j.jpba.2006.04.014
  12. V. Nuland, N.Venekamp, N. de Vries, K.A.M.D. Jong, H. Rosing, J.H. Beijnen. Development and validation of an UPLC-MS/MS method for the therapeutic drug monitoring of oral anti-hormonal drugs in oncology. Journal of Chromatography B. 2019; 1106: 26. https://doi.org/10.1016/j.jchromb.2019.01.001
  13. P. Sancheti, V. M. Vyas, Manali Shah, Poonam Karekar, and Y. V. Pore. Spectrophotometric estimation of bicalutamide in tablets.  Indian Journal of Pharmaceutical Sciences. 2008; 70:  810.doi: 10.4103/0250-474X.49131
  14. Prem Kumar, R. Suthakaran, Ch. Shankar, S. Ghouse, J. Beula, R. Naresh. RP- HPLC Method Development and Validation of Bicalutamide and Atenolol in its Pure Dosage Forms. Asian Journal of Pharmaceutical Analysis. 2020; 10(1): 15. https://doi.org/10.5958/2231-5675.2020.00004.6
  15. Li, H. Wang, Y. Pan, S. Wang, Z. Zhang, H. Zhou, M. Xu and X. Liu, Front. Identification of bicalutamide resistance-related genes and prognosis prediction in patients with prostate cancer. Endocrinol. 2023; 14: 1. https://doi.org/10.3389/fendo.2023.1125299
  16. Izady, F.Khatami, Z.Ahadi, H.Roudgari, and S.Mohammad Kazem Aghamir, Updates on Overcoming Bicalutamide Resistance: A Glimpse into Resistance to a Novel Antiandrogen. ACS Pharmacology & Translational Science. 2024; 7: 905.  https://doi.org/10.1021/acsptsci.3c00299
  17. Shapiro, J.  Hair Disorders: Current Concepts in Pathophysiology, Diagnosis and Management, An Issue of Dermatologic Clinics. Elsevier Health Sciences. 2012; 1st Edition, 31(1): ISBN978-1-4557-7169-1.