P. Ravi Sankar, K. Saisneha Latha, A. Bhavani Sailu, SK. Taheera, B. Madhuri
P. Ravi Sankar*, K. Saisneha Latha, A. Bhavani Sailu, SK. Taheera, B. Madhuri
Department of Pharmaceutical Analysis, Vignan Pharmacy College, Vadlamudi, Guntur - 522 213, Andhra Pradesh, India.
Volume - 14,
Issue - 3,
Year - 2021
A simple, precise, accurate, highly sensitive, rapid, and reproducible high-performance liquid chromatographic method was developed for the determination of Pazopanib Hydrochloride in bulk and tablet dosage form. Good quality chromatographic separation of Pazopanib Hydrochloride was carried out using Eclipse plus C18 column (4.5mm i.d. X 150mm, 3.5µm particle size) (based on 99.999% ultra-high purity silica) using mobile phase that containing 0.1% Orthophosphoric acid: Acetonitrile (55:45% v\v) at a flow rate of 1.0mL/minute. The ?max of Pazopanib Hydrochloride in the mobile phase was found to be 271.4nm. It had a retention time of 1.430 min. The calibration curve was in the linear function of the drug in the concentration range of 2-10µg/mL (r2 = 0.999) for the HPLC method. The regression equation for Pazopanib Hydrochloride was found to be Y =70095 x + 28022 for HPLC. The Detection Limit (DL) and Quantitation Limit (QL) results of Pazopanib Hydrochloride were found to be 0.167548µg/mL 0.055290µg/mL for HPLC method, respectively. The developed methods are validated in pursuance of ICH Q2 (R1) guidelines. The method was linear, precise, accurate with recoveries in the range of 98 – 102% and minimum values of % RSD indicate the accuracy of the method. The % assay of the Pazopanib Hydrochloride was found to be 99.85±12, which was in good agreement with the labelled claim. The detailed quantitative results of the study show that this method is precise, accurate, cost-effective, and robust. Thus, the developed gradient RP-HPLC method can be successfully practiced for the routine quality control analysis of Pazopanib Hydrochloride in a pharmaceutical formulation.
Cite this article:
P. Ravi Sankar, K. Saisneha Latha, A. Bhavani Sailu, SK. Taheera, B. Madhuri. Development and Validation of RP-HPLC Method for the Determination of Pazopanib Hydrochloride (A Tyrosine Kinase Inhibitor) in Pharmaceutical Dosage Form. Research J. Pharm. and Tech 2021; 14(3):1549-1554. doi: 10.5958/0974-360X.2021.00273.0
P. Ravi Sankar, K. Saisneha Latha, A. Bhavani Sailu, SK. Taheera, B. Madhuri. Development and Validation of RP-HPLC Method for the Determination of Pazopanib Hydrochloride (A Tyrosine Kinase Inhibitor) in Pharmaceutical Dosage Form. Research J. Pharm. and Tech 2021; 14(3):1549-1554. doi: 10.5958/0974-360X.2021.00273.0 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-3-63
1. Remy B Verheijen, et al. Fast and Straight forward Method for the Quantification of Pazopanib in Human Plasma Using LC-MS/MS. Therapeutic Drug Monitoring. 2018; 40(2): 230-236.
2. Remy B Verheijen, Sander Bins, et al. Development and Clinical Validation of an LC-MS/MS Method for the Quantification of Pazopanib in DBS. Bioanalysis. 2016; 8(2): 123-34.
3. Mukul Minocha, Varun Khurana, et al. Determination of Pazopanib (GW-786034) in Mouse Plasma and Brain Tissue by Liquid Chromatography- Tandem Mass Spectrometry (LC/MS-MS). J Chromatogr B Analyst Technol Biomed Life Sci. 2012; 90: 85-92.
4. Rolf W Sparidans, Tahani T A Ahmed, et al. Liquid Chromatography- Tandem Mass Spectrometric Assay for Therapeutic Drug Monitoring of the Tyrosine Kinase inhibitor Pazopanib in Human Plasma. J Chromatogr B Analyst Technol Biomed LIFE Sci. 2012;905:137-40.
5. Claire Pressiat, Huu-Hien Huynh, Alain Ple, et al. Development and Validation of a Simultaneous Quantification Method of Ruxolitinib, Vismodegib, Olaparib, and Pazopanib in Human Plasma Using Liquid Chromatography Coupled With Tandem Mass Spectrometry. The Drug Monit. Journal. 2018; 40(3):337-343.
6. Prinesh N Patel, Pradipbhai D Kalariya, et al. Characterization of Forced Degradation Products of Pazopanib Hydrochloride by UHPLC-Q-TOF/MS and in Silico Toxicity Prediction. Journal of Mass Spectrometry. 2015; 50(7):918-28.
7. Vanesa Escudero-Ortiz, et al. Development and Validation of an HPLC-UV Method for Pazopanib Quantification in Human Plasma and application to Patients with Cancer in Routine Clinical Practice. Therapeutic Drug Monitoring.2015; 37(2:172-9.
8. Musty Sharada, Ravichandra Babu R, et al. Determination and Characterization of process impurities in Pazopanib hydrochloride Drug Substance. International Journal of Pharmacy and Pharmaceutical Sciences.2016;8:0975-1491.
9. Ravi Sankar P, Saisneha Latha K, Srinivasa Babu P, Development and validation of UV spectrophotometric method for the determination of Pazopanib Hydrochloride in pharmaceutical dosage form. Int. J. Pharm. Sci. Rev. RES. 2020; 61(2): 13-18.
10. G. Chaitanya and A. K. M. Pawar. Development and Validation of UV spectrophotometric method for the determination of Pazopanib hydrochloride in bulk and tablet formulation. Journal of Chemical and Pharmaceutical Research. 2015; 7(12): 219-225.
11. Ravi Sankar P, Sai Snehalatha K, Tabassum Firdose Shaik, Srinivasa Babu P. Applications of HPLC in Pharmaceutical Analysis. Int. J. Pharm. Sci. Rev. Res. 2019; 59(1): 117-124.
12. Bokai Ma, Xin Lei Gou, et al. Application of high-performance liquid chromatography in food and drug safety analysis. Journal of food safety and quality. 2016; 7: 295-4298.
13. Ravi Sankar P, Rajyalakshmi G, Devadasu Ch, Devala Rao G. Instant tips for a right and effective approach to solve HPLC troubleshooting, Journal of Chemical and Pharmaceutical Sciences. 2014; 7(3): 191-206.
14. Ravisankar P, Naga Navya Ch, Pravallika D, Navya Sri D. A review on step-by-step analytical method validation. IOSR Journal of Pharmacy. 2015; 5:7-19.
15. Ravisankar P, Gowthami S, Devala Rao G. A review on analytical method development. Indian journal of research in pharmacy and Biotechnology. 2014; 2: 1183-1195.
16. Panchumarthy Ravisankar, Anusha S, Supriya K, Ajith Kumar U. Fundamental chromatographic parameters. Int. J. Pharm. Sci. Rev. Res. 2019; 55(2):46-50.
17. ICH Q2 (R1), Validation of analytical procedures, Text, and methodology. International Conference on Harmonization, Geneva, 2005, 1-17.