ABSTRACT:
Background: Paclitaxel (PTX) is well known anticancer drug used for treatment of a wide range of cancers. Tamoxifen (TMX) is a gold-standard drug for the treatment of breast cancer. They show synergistic action against breast cancer. Quantitative analytical methods are still not available for simultaneous quantification of these drugs. So for the first time, we developed and validated a new systematic analytical technique for simultaneous estimation of PTX and TMX in nanoformulations. Objective: Systematic method development and validation of Paclitaxel and Tamoxifen by RP-HPLC for simultaneous estimation in nanoformulations. Methods: PTX and TMX were successfully separated and quantified using RP-HPLC. The detection was done based on the isobastic point of both drugs. Thermo Scientific Company's C18 column, measuring 2.5 cm × 4.5 cm x 5 µm, was utilized for separation. A 50:50 (vol/vol) ratio of ACN: Phosphate buffer solution (pH 3.0) was employed as the mobile phase, with a flow rate of 1 mL/minute. The detection was done at 235nm. The method was developed and validated as per the criteria. The developed method was then evaluated for applicability by detecting both analytes in prepared SLN and LPHNPs. Results: The well-resolved separate peaks of both analytes were found and distinct RT for PTX and TMX. The linear relationship of both the analytes against concentration was found over the concentration range of 0.25-9 µg/mL. The PTX RT was 10.358 minutes and that of TMX was 12.57 minutes. Every criterion for method validation fell within the acceptable range. The method is precise with inter-day and intra-day precision and shows a %RSD of < 2%.
Cite this article:
Mahavir Narwade, Kavita R. Gajbhiye. Systematic Method Development and Validation of Paclitaxel and Tamoxifen by RP-HPLC for Simultaneous Estimation in Nanoformulations. Research Journal of Pharmacy and Technology.2024; 17(8):3976-2. doi: 10.52711/0974-360X.2024.00617
Cite(Electronic):
Mahavir Narwade, Kavita R. Gajbhiye. Systematic Method Development and Validation of Paclitaxel and Tamoxifen by RP-HPLC for Simultaneous Estimation in Nanoformulations. Research Journal of Pharmacy and Technology.2024; 17(8):3976-2. doi: 10.52711/0974-360X.2024.00617 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2024-17-8-65
7. REFERENCES:
1. Du Y. Wan Z. Wang T. He W. Zhou W. Li M. Li X. Improved antitumor activity of novel redox-responsive paclitaxel-encapsulated liposomes based on disulfide phosphatidylcholine. Molecular Pharmaceutics. 2019; 17(1): 262-273. https://doi.org/10.1021/acs.molpharmaceut.9b00988
2. Zhai J. Luwor RB. Ahmed N. Escalona R. Tan FH. Fong C. Tran N. Paclitaxel-loaded self-assembled lipid nanoparticles as targeted drug delivery systems for the treatment of aggressive ovarian cancer. ACS Applied Materials and Interfaces. 2018; 10(30): 25174-25185. https://doi.org/10.1021/acsami.8b08125
3. Wang Z. Ling L. Du Y. Yao C. Li X. Reduction responsive liposomes based on paclitaxel-ss-lysophospholipid with high drug loading for intracellular delivery. International Journal of Pharmaceutics. 2019; 564: 244-255. https://doi.org/10.1016/j.ijpharm.2019.04.060
4. Zhang J. Wang L. Chan HF. Xie W. Chen S. He C. Chen M. Co-delivery of paclitaxel and tetrandrine via iRGD peptide conjugated lipid-polymer hybrid nanoparticles overcome multidrug resistance in cancer cells. Scientific Reports. 2017; 7(1): 1-14. https://doi.org/10.1038/srep46057
4. Mangla B. Beg S. Alam O. Ahsan W. Haque A. Patel KS. Kohli K. Systematic development and validation of RP-HPLC method for simultaneous estimation of tamoxifen and sulphoraphane with specific application for nanolipidic formulations. Arabian Journal of Chemistry. 2020; 13(11): 7909-7920. https://doi.org/10.1016/j.arabjc.2020.09.022
5. Varthya M. Pawar H. Singh C. Dora CP. Jena SK. Suresh S. Development of novel polymer-lipid hybrid nanoparticles of tamoxifen: in vitro and in vivo evaluation. Journal of Nanoscience and Nanotechnology. 2016; 16(1): 253-260. https://doi.org/10.1166/jnn.2016.10651
6. Beg S. Jain A. Kaur R. Panda SS. Katare OP. Singh B. QbD-driven development and validation of an efficient bioanalytical UPLC method for estimation of olmesartan medoxomil. Journal of Liquid Chromatography and Related Technologies. 2016; 39(13): 587-597. https://doi.org/10.1080/10826076.2016.1206023
7. Ganorkar SB. Dhumal DM. Shirkhedkar AA. Development and validation of simple RP-HPLC-PDA analytical protocol for zileuton assisted with Design of Experiments for robustness determination. Arabian Journal of Chemistry. 2017; 10(2): 273-282. https://doi.org/10.1016/j.arabjc.2014.03.009
8. Varade PR. Narwade MG. Tambe VN. Method Development and Validation of Irbesartan by RP-HPLC Method. Research Journal of Science and Technology, 2020; 12(2): 131-135. https://doi.org/10.5958/2349-2988.2020.00016.9
9. Vemireddy S. Gandla K. Jyothsna B. Bindu M. A validated RP-HPLC method for quantitative estimation of Guaifenesin in bulk and pharmaceutical dosage forms. Research Journal of Pharmacy and Technology 2023; 16(1): 111-4. DOI: 10.52711/0974-360X.2023.00020
10. Katolkar P. Gaydhane N. Vidhate S. Gattewar A. Motghare A. Baheti J. Analytical Method Development and Validation for Estimation of Lapatinib in Formulation by RP-HPLC with Stability Indicating. Research Journal of Pharmacy and Technology 2023; 16(7): 3125-1. DOI: 10.52711/0974-360X.2023.00514
11. Dhanalakshmi K. Jaswanth A. Subramainan E. Suntharaselvi T. RP-HPLC Method Validation for Estimation of Tenofovir Disoproxil Fumarate in Pharmaceutical Oral Dosage Form. Research Journal of Pharmacy and Technology 2023; 16(2): 777-0. DOI: 10.52711/0974-360X.2023.00133
12. Patel MM. Patel D. Shah U. Kachhiya HM. A Simple, Precise, and Sensitive RP-HPLC Method for Quantification of Teneligliptin Hydrobromide and Metformin Hydrochloride: Development and Validation. Research Journal of Pharmacy and Technology 2023; 16(2): 495.1 DOI: 10.52711/0974-360X.2023.00084
13. Saklani R. Tiwari AK. Yadav PK. Yadav P. Chourasia MK. Validated HPLC-UV method for simultaneous estimation of Paclitaxel and Doxorubicin employing Ion Pair Chromatography: Application in Formulation Development and Pharmacokinetic Studies. BioMed Research International. 2022; 1-11. https://doi.org/10.1155/2022/7708235
14. Jagtap K. Patel S. Shah U. Dissolution method development and validation for simultaneous determination of Metformin and Teneligliptin in pharmaceutical tablets. Research Journal of Pharmacy and Technology 2023; 16(1): 133-9. DOI: 10.52711/0974-360X.2023.00025
15. Reddy AR. Devicharan R. Rama Rao T. Analytical RP-HPLC method development and validation for simultaneous estimation of Emtricitabine, Tenofovir and Bictegravir. Research Journal of Pharmacy and Technology 2023; 16(8): 3722-6. DOI: 10.52711/0974-360X.2023.00614
16. Gupta SK. Sachan N. Chandra P. Sharma AK. A Facile RP-HPLC Strategy for Sensitive Detection and Stability Study of Dacarbazine in API and in Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology 2023; 16(4): 1674-8. DOI: 10.52711/0974-360X.2023.00274
17. Gandi S. Manikandan A. Venkat Rao S. Novel Stability indicating RP-UPLC Method for simultaneous Determination of Ivabradine and Metoprolol drug materials in bulk and their Pharmaceutical Dosage Forms. Research J. Pharm. and Tech. 2020; 13(1): 250-254.
18. Praveena J. Guru BR. Simultaneous estimation of paclitaxel and curcumin in nano-formulation: Stability analysis of drugs, optimization and validation of HPLC method. Journal of Applied Pharmaceutical Science. 2021; 11(3): 071-083 https://doi.org/10.7324/JAPS.2021.110308
19. Bhavya Sri K. Begum M. Narmada. Sumakanth M. Development and Validation of a RP-HPLC Method for the determination of Venlafaxine hydrochloride in bulk and Pharmaceutical Dosage Forms. Research Journal of Pharmacy and Technology 2023; 16(2): 524-8. DOI: 10.52711/0974-360X.2023.00089
20. Sharma S. Ankalgi AD. Devi A. Ashawat MS. Development of Efficient Analytical method for the multicomponent analysis of Pravastatin Sodium and Nebivolol Hydrochloride in Bulk Drug by RP-HPLC. Research Journal of Pharmacy and Technology 2023; 16(5): 2477-4. DOI: 10.52711/0974-360X.2023.00408
21. Sen S. Ravindar B. Jala S. Dharabonia L. Rajeshwari K. Derivative Spectroscopic Method and RP-HPLC Method Development and Validation of Levofloxacin hemihydrate. Research Journal of Pharmacy and Technology 2023; 16(5): 2239-4. DOI: 10.52711/0974-360X.2023.00368
22. Alrobaian M. Panda SS. Almalki WH. Afzal O. Kazmi I. Alossaimi MA. Beg S. Development and Validation of Chemometrics-Assisted Green UPLC-MS/MS Bioanalytical Method for Simultaneous Estimation of Capecitabine and Lapatinib in Rat Plasma. Journal of Chromatographic Science. 2022; 60(6): 559-570. https://doi.org/10.1093/chromsci/bmab094
23. Shehada A. Abdelwahed W. Sakur AA. An Echo-Friendly and Validated RP-HPLC Method for Simultaneous Determination of Ciprofloxacine HCl and Fluocinolone Acetonide in Bulk and Dosage Forms. Research J. Pharm. and Tech 2020; 13(2): 715-718. DOI: 10.5958/0974-360X.2020.00136.5
24. Bahadur S. Deshmukh R. Validated HPLC and HPTLC Methods for Quantitative analysis of Syringic acid in Calendula officinalis. Research Journal of Pharmacy and Technology 2023; 16(4): 1925-0. DOI: 10.52711/0974-360X.2023.00316
25. Bonde S. Bonde CG. Prabhakar B. Quality by design based development and validation of HPLC method for simultaneous estimation of paclitaxel and vinorelbine tartrate in dual drug loaded liposomes. Microchemical Journal. 2019; 149: 103982. https://doi.org/10.1016/j.microc.2019.103982
26. Dinakaran V. Unnissa SH. Development and Validation of an RP-HPLC Method for the Simultaneous Estimation of Azelnidipine and Telmisartan in Pharmaceutical Tablet Dosage Form. Research Journal of Pharmacy and Technology 2023; 16(6): 2638-2. DOI: 10.52711/0974-360X.2023.00433
27. Panda M. Dadi V. Yarraguntla SR. Vara Prasad Rao K. RP-HPLC Method for Determination of Azelnidipine and Telmisartan in Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology 2023; 16(2): 509-3. DOI: 10.52711/0974-360X.2023.00086
28. Subramanian VB. Katari NK. Dongala T. Jonnalagadda SB. Stability‐indicating RP‐HPLC method development and validation for determination of nine impurities in apixaban tablet dosage forms. Robustness study by quality by design approach. Biomedical Chromatography. 2020; 34(1): e4719. https://doi.org/10.1002/bmc.4719
29. Makovi CM. Parker CH. Zhang K. Determination of Amygdalin in Apricot Kernels and Almonds Using LC-MS/MS. Journal of AOAC International. 2023; 106(2): 457-463. https://doi.org/10.1093/jaoacint/qsac154
30. Garg S. Chahal R. Kaushik D. Kumar R. Mittal V. RP-HPLC Method Development and Validation for Simultaneous Estimation of Rutin and Quercetin in Morus alba L. leaf extract. Research Journal of Pharmacy and Technology 2023; 16(5): 2327-5. DOI: 10.52711/0974-360X.2023.00383
31. Sandhu PS. Beg S. Katare OP. Singh B. QbD-driven development and validation of a HPLC method for estimation of tamoxifen citrate with improved performance. Journal of Chromatographic Science. 2016; 54(8): 1373-1384. https://doi.org/10.1093/chromsci/bmw090
32. Venkata N. Jajula ID. Pawar AK. Development and Validation of Stability Indicating Method for Simultaneous Estimation of Paritaprevir, Ombitasvir, and Ritonavir in Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2023; 16(5): 2306-0. DOI: 10.52711/0974-360X.2023.00379
33. Jagdale S. Narwade M. Sheikh A. Md S. Salve R. Gajbhiye V. Kesharwani, P. Gajbhiye KR. GLUT1 transporter-facilitated solid lipid nanoparticles loaded with anti-cancer therapeutics for ovarian cancer targeting. International Journal of Pharmaceutics. 2023: 637: 122894. https://doi.org/10.1016/j.ijpharm.2023.122894