Poojari Venkatesh, Umasankar Kulandaivelu, GSN Koteswara Rao, Guntupalli Chakravarthi, Rajasekhar Reddy Alavala, Bandlamuri Rajesh
Poojari Venkatesh*, Umasankar Kulandaivelu, GSN Koteswara Rao, Guntupalli Chakravarthi, Rajasekhar Reddy Alavala, Bandlamuri Rajesh
K L College of Pharmacy, Koneru Lakshmaiah Education Foundation, Vaddeswaram, Guntur, Andhra Pradesh, India 522 502.
Volume - 15,
Issue - 1,
Year - 2022
Darolutamide is an orally active, second generation non-steroidal anti-androgen. The objective of this study was to develop a simple and fast stability indicating method for the determination of Darolutamide in bulk and tablets. Darolutamide was eluted on a Zorbax SB-C18 column (100X2.1mmX1.8µ) with a mobile phase of 8mM ammonium acetate, pH: 5.4: acetonitrile (66:34 v / v) in isocratic mode at a flow rate of 0.4 ml / min. The analyte was quantified using a 272 nm PDA detector. The chromatograms of darolutamide obtained with this method showed a well resolved retention time at 0.83 min of its excipients and degradation products. The area of the peak with respect to the concentration calibration curves, which were linear from 70 to 210 µg / ml, had a regression coefficient (r2) greater than 0.999. The detection limit (LOD) and the limit of quantification (LOQ) were found at 1.80 and 6.01 µg/mL respectively. Accuracy and precision have been determined and perfectly matched to the ICH standards. The study showed that the proposed UPLC method was simple, fast, robust and reproducible, which can be used for the evaluation of the purity and stability of the drug without interference from excipients or decomposition products of active pharmaceutical ingredients.
Cite this article:
Poojari Venkatesh, Umasankar Kulandaivelu, GSN Koteswara Rao, Guntupalli Chakravarthi, Rajasekhar Reddy Alavala, Bandlamuri Rajesh. Development and validation of a stability indicating UPLC method for determination of Darolutamide in its tablet formulation. Research Journal of Pharmacy and Technology. 2022; 15(1):165-0. doi: 10.52711/0974-360X.2022.00027
Poojari Venkatesh, Umasankar Kulandaivelu, GSN Koteswara Rao, Guntupalli Chakravarthi, Rajasekhar Reddy Alavala, Bandlamuri Rajesh. Development and validation of a stability indicating UPLC method for determination of Darolutamide in its tablet formulation. Research Journal of Pharmacy and Technology. 2022; 15(1):165-0. doi: 10.52711/0974-360X.2022.00027 Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-1-27
1. R.L. Siegel, K.D. Miller, A. Jemal. Cancer Statistics 2017. CA: a Cancer Journal for Clinicians. 2017; 67(2): 7-30.
2. C.J. Ryan, M.L. Cheng. Abiraterone acetate for the treatment of prostate cancer. Expert Opinion on Pharmacotherapy. 2013;14 (5): 91-96.
3. H.I. Scher, C.L. Sawyers. Biology of progressive, castration-resistant prostate cancer: directed therapies targeting the androgen-receptor signaling axis. Journal of Clinical Oncology. 2005; 23 (12): 8253-8261.
4. L.J. Scott. Abiraterone acetate: A review in metastatic castration-resistant prostate cancer. Drugs. 2017; 77(13):1565-1576.
5. A. Mullard. 2012 FDA drug approvals. Nature Reviews Drug Discovery. 2013; 12 (8): 87-90.
6. Z.T. Al-Salama. Apalutamide: First Global Approval. Drugs. 2018; 78 (2): 699-705.
7. A.M. Moilanen, R. Riikonen, R. Oksala et.al., Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies. Scientific Reports. 2017; 5 (5): 12007-12015.
8. K. Fizazi, C. Massard, N.D. James. ODM-201, a new generation androgen receptor inhibitor for castration-resistant prostate cancer: preclinical and phase I data. American Society of Clinical Oncology Journal. 2013; 31 (suppl 6) Abstract 65.
9. A. Moilanen, R. Riikonen, R. Oksala. ODM-201 - new generation antiandrogen with excellent antiandrogenic and antitumor activity in nonclinical models of CRPC. European Journal of Cancer. 2013; 49 (suppl 2) Abstract 685.
10. Orion Pharma Clinical Study Code: 3104001/EN3386-201 (accessed on 7 June 2020).
11. FDA approved drugs, Available from: https://www.accessdata.fda.gov/ drugsatfda_docs/ label/2019/212099Orig1s000lbl.pdf (accessed on 7 June 2020).
12. FDA approved drugs list, Available from:https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-non-metastatic-castration-resistant-prostate-cancer#:~:text= FDA%20approves% 20darolutamide %20for%20non% 2Dmetastatic%20castration%2 Dresistant% 20prostate% 20cancer,- Share&text=On %20July%2030 %2C%202019%2C%20the, metastatic% 20 castration %2 Dresistant%20prostate%20cancer. (accessed on 7 June 2020).
13. Balaji N, Sulochana SP, Saini NK et. al., Validation of a chiral LC-MS/MS-ESI method for the simultaneous quantification of darolutamide diastereomers in mouse plasma and its application to a stereoselective pharmacokinetic study in mice. Biomed Chromatogr. 2018; 32(5): e4173-19.
14. S. Dittakavi, P.K.V.S.P. Nagasuri, S.P. Sulochana. et. al., LC-MS/MS-ESI method for simultaneous quantification of darolutamide and its active metabolite, ORM-15341 in mice plasma and its application to a pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis. 2017; 145 (4) 454-461.
15. Balaji N, Sulochana SP, Saini NK et.al., Validated Chiral LC-ESI-MS/MS Method for the Simultaneous Quantification of Darolutamide Diastereomers and Its Active Metabolite in Mice Plasma: Application to a Pharmacokinetic Study. Drug Res (Stuttg). 2018;68(11):615-624.
16. Ashok Zakkula, Vinay Kiran, Umesh Todmal et. al., RP-HPLC-UV Method for Simultaneous Quantification of Second Generation Non-Steroidal Antiandrogens Along with their Active Metabolites in Mice Plasma: Application to a Pharmacokinetic Study. Drug Research. 2019; 69(10):537-544.
17. M.M. Eswarudu, M. Chinna Eswaraiah, K. Prasanna Kumar, K. Sudhakar. Ultra Performance Liquid Chromatography (UPLC): A Preeminent Technique in Pharmaceutical Analysis. Research J. Pharm. and Tech. 5(12): Dec. 2012; Page 1484-1489.
18. Kamepalli Sujana, P. Jagadish, S. Venu, T. Pavani Priyanka. Stability Indicating Validated UPLC Method for Determination of Nebivolol HCl in Bulk and Pharmaceutical Dosage Form. Research J. Pharm. and Tech. 2016; 9(5): 533-537.
19. Mohamed Mustafa, S. Amuthalakshmi, C.N. Nalini. Simultaneous UPLC Estimation of Fexofenadine HCl and Montelukast Sodium Tablets. Research J. Pharm. and Tech. 2017; 10(2): 557-561.
20. V. Mohan Goud, A. Srinivasa Rao, S.V. Phanindra, S. Pragati Ranjan. Development and Validation of RP-HPLC Method for Assay of Seratrodast in Pharmaceutical Dosage Form. Asian J. Research Chem. 6(8): August 2013; Page 749-751.
21. Mohammad Yunoos, Ch. Bharadwaj, V. Sandeep, S. Rajesh, Ch. Krishna. Determination of Itraconazole in Bulk and Capsule Dosage Form by a Validated Isocratic RP-HPLC Method. Asian J. Research Chem 8(4): April 2015; Page 236-240.
22. Mahaveer Singh, S.G. Kashkhedikar, Love Soni, Abhinav Garg Tripti Gandhi, Amrish Patel. Development of RP-HPLC Method for Estimation of Carvedilol in Tablet Formulations. Research J. Pharm. and Tech. 1(1): Jan.-Mar. 2008; Page 18-21.
23. M. Padmalatha, Syeda Kulsum, K. Vanitha Prakash. High Performance Liquid Chromatographic Estimation of Prulifloxacin in Pharmaceutical Dosage Form. Research J. Pharm. and Tech. 4(5): May 2011; Page 759-761.
24. Venkataramana N.V., Nivedita R Desai, Sreenivasa S, Chaluvaraju K. C., Aruna Kumar D. B. Development and Validation of a Chromatographic Method for the Estimation of Rifampicin in Bulk and Pharmaceutical Formulations. Research J. Pharm. and Tech 2016; 9(12):2191-2198.
25. Rupali Tambe, Someshwar Mankar, Santosh Dighe. Analytical Method Development and Validation of Paliperidone: A Review. Research J. Science and Tech. 2020; 12(1):23-35.
26. B. Mohammed Ishaq, Dr. K. Vanitha Prakash, Dr. G. Krishna Mohan. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Tapentadol and Paracetamol in Bulk Drug and its Pharmaceutical Dosage Form. Research J. Pharm. and Tech. 2014; 7(2): 208-212.
27. ICH Q2 (R1), Validation of Analytical Procedures: Text and Methodology, 2005 Available from: https://database.ich.org/sites/default/files/Q2_R1__Guideline.pdf
28. ICH Guidelines, Q1 A(R2): Stability Testing of New Drug Substances and Products International Conference on Harmonisation, 2003.
Available from: www.fda.gov/ downloads/Regulatoryinformation/Guidances/ucm128204.pdf.