Author(s): Amitkumar J. Vyas, Pandey Meenakshi M., Ajay I. Patel, Ashok B. Patel, Nilesh K. Patel, Alpesh Chudasama


DOI: 10.5958/2231-5675.2020.00039.3   

Address: Dr. Amitkumar J. Vyas1, Pandey Meenakshi M.1*, Dr. Ajay I. Patel1, Dr. Ashok B. Patel1, Dr. Nilesh K. Patel1, Alpesh Chudasama2
1Pharmaceutical Quality Assurance Department, B. K. Mody Government Pharmacy College, Rajkot, Gujarat, India.
2Amneal Pharmaceutical Pvt. Ltd., 1 New England Avenue, Piscataway, NJ 07936, USA.
*Corresponding Author

Published In:   Volume - 10,      Issue - 4,     Year - 2020

This work was aimed to develop and validate simple, rapid and economical kinetic degradation method for the estimation of Darunavir ethanolate in bulk and tablet dosage form. The spectrum was determined at 267.40nm by using methanol as a solvent. The developed method was validated as per ICH guideline. Accuracy was obtained between 97.18 - 101.12%. LOD and LOQ was found to be 0.52µg/ml and 1.60µg/ml respectively. Darunavir ethanolate was subjected to acid, base, oxidation, photolytic and thermal degradation and the amount of degradation is in the range 10 – 40%. Results confirmed that this method can be employed for the estimation of Darunavir ethanolate in presence of its degradation product in tablet dosage form.

Cite this article:
Amitkumar J. Vyas, Pandey Meenakshi M., Ajay I. Patel, Ashok B. Patel, Nilesh K. Patel, Alpesh Chudasama. A Stress Degradation Kinetic study of Darunavir Ethanolate Bulk and Tablet Dosage form by UV Spectrophotometry. Asian J. Pharm. Ana. 2020; 10(4):213-217. doi: 10.5958/2231-5675.2020.00039.3

1.    Indian pharmacopoeia, Govt. of India Vol-I. Ghaziabad: Ministry of Health and Family Welfare, Published by The Indian Pharmacopoeia Commission 2018; pp. 1763.
2.    Zhengtong L, Yuan C, Yong W. HIV protease inhibitors: a review of molecular selectivity and toxicity. HIV AIDS Research and Palliative Care. 2015; 7: 95-104.
3.    Singh S and Bakshi M. Guidance on Conduct of Stress Tests to Determine Inherent Stability of Drugs. Pharmaceutical Technology. 2000,1-14.
4.    ICH- Harmonized Tripartite Guideline, "Validation of Analytical Procedures: Text and Methodology Q2 (R1)." International Conference on Harmonization, Geneva, Swizerland, 2005.
5.    Victoire de L, Erika FRDS, Michel D, Raphel P, Benedicte L, Helene S, Jean MM. High levels of atazanavir and darunavir in urine and crystalluria in asymptomatic patients. Journal of antimicrobial chemotherapy. 2013; 1850 – 1856.
6.    Abdul SM*, Bharath J, Rajender B, Shaik AR, Mohammad AB, Mohammad AS. Optimization of UV Spectrophotometric estimation of darunavir ethanolate in bulk drug and tablet formulations. International Journal of Pharmaceutical and Nanotechnology. 2016; 6: 3345-3348.
7.    Gholve SB, Asware BS, Kadam SC, Bhusnure OG, Thonte S. Development and validation of simple UV spectrophotometric method for the determination of darunavir ethanolate both in bulk and marketed dosage formulations. World Journal of Pharmaceutical Research. 2015; 4: 1276-1283.
8.    Dr. Buridi KR. Estimation of Tenofovir Disproxil Fumarate in Bulk and Formulations by Visible Spectrophotometric Methods. Research J. Pharma. Dosage Forms and Tech. 2013; 5(4): 221-226.
9.    Murugan S, Subhashis D, Pranabesh S, Niranjan BM. Simultaneous Estimation of Tenofovir Disoproxil Fumarate, Efavirenz and Lamivudine in Bulk and Tablet Dosage Form by UV Spectrophotometry. Research J. Pharm. and Tech. 2013; 6(2): 191-194.
10.    Govardhan PR, Kiran VK, Appala RVVSS, Raghu JR, Appala NR. Novel Spectrophotometric Method Development for the Estimation of Boceprevir in Bulk and in Pharmaceutical Formulations. Research J. Pharm. and Tech. 2017; 10(12): 4313-4316.
11.    Gurav SB, Prakash D, Anant DN, Sandeep WD. Spectrophotometric Method for Estimation of Efavirenz from Tablet Formulation. Asian J. Research Chem. 2011; 4(5): 754-756.
12.    Ashwini S, Madhavi S, Rajendra M, Rahul S, Dr. Anil J. Application of UV Spectrophotometric Methods for Simultaneous Estimation of Emtricitabine and Tenofovir Alafenamide Fumarate in Bulk. Asian Journal of Pharmacy and Technology. 2018; 8(2): 103-107.
13.    Janaki PP, Raveendra PR, Appala NR. Visible Spectrophotometric Estimation of Tenofovir Disoproxil Fumarate in Pharmaceutical Formulations Research J. Pharm. and Tech. 2011; 4(3): 447-449.
14.    Mohammad Y, Durga TP, Manikanta PSNC, Arjun KS, Mounica V, Siva D. A Simple Validated UV Spectrophotometric Method for the Estimation of Tenofovir disoproxil fumarate in bulk and Pharmaceutical dosage form. Research J. Pharm. and Tech. 2015; 8(4): 365-368.
15.    Ana CK, Herida R, Nunes S. Development and Validation of Infrared Spectroscopy Method for the Determination of Darunavir in Tablets. Physical Chemistry. 2013; 3(1): 1-6.
16.    Satyanarayana L, Naidu SV, Narasimha MR, Alok K, Suresh K. The Estimation of Darunavir in Tablet dosage form by RP-HPLC. Asian J. Res. Pharm. Sci. 2011; 1(3): 74-76.
17.    Ramisetti NR, Kandukuri NK, Bompelli SK. Liquid chromatographic separation and thermodynamic investigation of stereoisomers of darunavir on Chiralpak AD-H column. Journal of Pharmaceutical and Biomedical Science. 2012; 00: 1–7.
18.    Antonio DA, Mrco S, Mauro S, Baietto L, Stefano B, Lura T, Giovanni DP. HPLC – MS method for the simultaneous quantification of the new HIV protease inhibitor darunavir and 11 other antiretroviral agents in plasma of HIV- infected patients. Journal of Chromatography B1 859. 2007; 234 – 240.
19.    Raveendra BG, Ramprasad AL, Srinivasu P, Jayachandra RP, Rao JVLNS. New RP-HPLC Method for the determination of Darunavir in Tablet Dosage form. Asian J. Pharm. Res. 2011; 1(1): 10-14.
20.    Ambavaram VBR, Jafariah J, Azmi BA, Zaiton AM, Khalid U, Juhaizah T, Gajulapalle M. Development and validation of a rapid ultra high performance liquid chromatography with tandem mass spectrometry method for the simultaneous determination of darunavir, ritonavir, and tenofovir in human plasma: Application to human pharmacokinetics. Journal of sepration science. 2015; 38: 2559 – 2752.
21.    Raveendra GB, Lakshmana AR, Venkateswara R. Development and validation of novel HPLC method for estimation of darunavir in pharmaceutical formulations. International Journal of Research in Pharmacy and Chemistry. 2013; 3(2): 438-443.
22.    Laura E, Victoria W, John T, Andrew H, Marco S, Saye K, David B. Validation of a rapid and sensitive high performance liquid chromatography tendem mass spectroscopy assay for the simultaneous determination of existing and new anti retroviral compounds. Journal of chromatography B. 2010; 1455 – 1465.
23.    ZhengCai L, Fang Y, Minna Y, Yonghui L, Zhijiao S. Simultaneous determination of antiviral drugs in chicken tissues by ultra high performance liquid chromatography with tandem mass spectrometry. Journal of sepration science. 2015; 38: 1625 – 1812.
24.    Ramisetti NR, Bondigala R, Kondapalli S. RP – HPLC separation and characterization of unknown impurities of a novel HIV protease inhibitor Darunavir by ESI – MS and 2D NMR spectroscopy. Journal of pharmaceutical and biomedical analysis. 2013; 186-191.
25.    Nageswara RR, Guru KP. LC – Q – TOF-MS/MS determination of darunavir and its metabolites in rat serum and urine application of pharmacokinetics. Journal of Pharmaceutical and Biomedical Science. 2014; 92-98.
26.    Lauriance G, Stephanie C, Elisabeth R, Odile L, Jean PV, Gerard P, Vincent J. Quantification of darunavir (TMS 114) in human plasma by high performance liquid chromatography with ultra violet detection. Journal of chromatoghraphy B 857. 2007; 327 – 331.
27.    Naser LR, Nichole RW, Steven HJ, Angela DMK. A novel LC ESI MS method for the simultaneous determination of etravirine, darunavir and ritonavir in human blood plasma. Talanta. 2009; 172-1378.
28.    Rob TH, Carollien G, Alderden L, Michel XH, Eric CM, Alwin DR, Josh HB. Fast and simultaneous determination of darunavir and eleven other antiretroviral drugs for therapeutic drug monitoring: method development and validation for the determination of all currently approved HIV protease inhibitors and non- nucleoside reverse transcriptase inhibitors in human plasma by liquid chromatography coupled with electrospray ionization tandem mass spectrometry. Rapid Communications in Mass Spectrometry. 2007; 21: 2505–2514.
29.    Reddy VB, Zulkifi Y, Jafariah J, Azmi BA, Zaiton AM, Khalid U, Juhaizah T. Development and validation of a selective, sensitive and stability indicating UPLC-MS/MS method for rapid, simultaneous determination of six process related impurities in darunavir drug substance. Journal of Pharmaceutical and Biomedical Analysis. 2016; 5-26.
30.    Tulsidas M, Pranav SS. Validation of Simultaneous Quantitative Method of HIV Protease Inhibitors Atazanavir, Darunavir and Ritonavir in Human Plasma by UPLC-MS/MS. The Scientific World Journal. 2014; 1-12.
31.    Madhavi S, Rameela AR. Development and validation of RP-UPLC method for simultaneous estimation of Cobicistat and Darunavir. Research J. Pharm. and Tech. 2017; 10(12): 4343-4349.
32.    Bhavini NP, Bhanubhai NS, Changanbhai NP, Hiral JP. A Simple and Sensitive HPTLC Method for Quantitative Analysis of Darunavir Ethanolate Tablets. Journal of Planar Chromatography 24. 2011; 3: 232–235.
33.    Bokka R, Sisla R, Rentam Kiran KR, Kothpalli H, Vanka Uma MS and Potturi Sita D. HPTLC method for determination of darunavir in rat plasma and its application in pharmacokinetic studies. Journal of Liquid Chromatography and Related Technologies. 2013; 167-179.

Recomonded Articles:

Author(s): G. Raveendra Babu, J. Srinivasa Rao, K. Suresh kumar, P. Jayachandra Reddy

DOI:         Access: Open Access Read More

Author(s): Amitkumar J. Vyas, Dhruvanshi A. Gol, Ajay I. Patel, Ashok B. Patel, Nilesh K. Patel, Alpesh Chudasama

DOI: 10.5958/2231-5675.2020.00032.0         Access: Open Access Read More

Author(s): Amitkumar J. Vyas, Pandey Meenakshi M., Ajay I. Patel, Ashok B. Patel, Nilesh K. Patel, Alpesh Chudasama

DOI: 10.5958/2231-5675.2020.00039.3         Access: Open Access Read More

Asian Journal of Pharmaceutical Analysis (AJPA) is an international, peer-reviewed journal, devoted to pharmaceutical analysis...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/2231–5675 

Popular Articles

Recent Articles