Punna Venkateshwarlu, Mehul M. Patel
Punna Venkateshwarlu1*, Mehul M. Patel2
1Research Scholar, Department of Pharmaceutical Analysis and Quality Assurance, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, Changa - 388421, Anand (Dt), Gujarat, India.
2Department of Pharmaceutical Chemistry, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, Changa - 388421, Anand (Dt), Gujarat, India.
Volume - 14,
Issue - 8,
Year - 2021
A simple, accurate, RP HPLC method was developed by this study determination of lenalidomide. This method is developed by Shimadzu LC -2010 HT by using C18 (250 X 4.6 X mm X 5µ) column in solvents Phosphate buffer: Acetonitrile (55:45) v/v as mobile phase and the temperature was maintained at 25°C. The mobile phase flow rate 1ml/min was pumped and sample wavelength was detected at 242nm by ultraviolet -visible spectrophotometer. The retention time was found 2.5 min. The number of theoretical plates and tailing factor for lenalidomide was observed 16199.817 (NLT 2000) and 1.128 (NMT 2). The method was validated for analytical standards such as linearity, accuracy, precision, system suitability and robustness. LOD and LOQ values obtained from regression of lenalidomide 0.058 and 0.174µg/ml. The regression equation of validated method for lenalidomide is Y=5223x+183075. In wide range of 25 to 150 (µg/ml) the linearity was observed. The method was validated and a recovery study indicates accuracy of this method. The Retention time less compared to established methods. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Lenalidomide in bulk drug and in its pharmaceutical dosage forms.
Cite this article:
Punna Venkateshwarlu, Mehul M. Patel. Method Development and Validation of Degradation Studies of Lenalidomide by RP-HPLC. Research Journal of Pharmacy and Technology. 2021; 14(8):4281-6. doi: 10.52711/0974-360X.2021.00744
Punna Venkateshwarlu, Mehul M. Patel. Method Development and Validation of Degradation Studies of Lenalidomide by RP-HPLC. Research Journal of Pharmacy and Technology. 2021; 14(8):4281-6. doi: 10.52711/0974-360X.2021.00744 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-8-50
1. Kastritis E, Dimopoulos MA. The evolving role of lenalidomide in the treatment of hematologic malignancies. Expert Opin Pharmacother. 2007; 8: 497–509.
2. Yogeshwar Reddy M, Ramesh V, Kista Reddy Ch, Venugopal N, Saravanana G, Suryanarayana M.V, Shyam B, Sunder, Surendranath Reddy R, Raju G. Validated Chromatographic Method for the Determination of Process Related Genotoxic Impurity in Lansoprazole. Asian J. Research Chem.2011; 4(6): 965-967.
3. Tariman JD. Lenalidomide: a new agent for patients with relapsed or refractory multiple myeloma. Clin J Oncol Nursing. 2007; 11: 569–574.
4. Preeti Tiwari, Rakesh K Patel. Quantification of Quercetin and Rutin in Arjunarishta Prepared by Traditional and Modern Methods by Validated HPTLC Densitometry. Asian J. Research Chem.2011; 4(6): 1019-1024.
5. Shah SR, Tran TM. Lenalidomide in myelodysplastic syndrome and multiple myeloma. Drugs. 2007; 67: 1869– 1881.
6. Falco P, Cavallo F, Larocca A, Liberati AM, Musto P, Boccadoro M, Palumbo A. Lenalidomide and its role in the management of multiple myeloma. Expert Rev Anticancer Ther. 2008; 8: 865–874.
7. Hideshima T, Richardson PG, Anderson KC. Current therapeutic uses of lenalidomide in multiple myeloma. Expert Opin Invest Drugs. 2006; 15: 171–179.
8. Bhushan Pingale, Ravi Tiwari. Development and Validation of an RP-HPLC Method for the Estimation of Bupropion Hydrochloride. Research J. Pharm. and Tech.2011; 4(9): 1480-1482.
9. Anand Babu K, Kumudhavalli M.V, Sainath Reddy K, Jaykar B. Stability Indicating UV-Spectrophotometric Determination of Nevirapine in Pharmaceutical Dosage Form. Research J. Pharm. and Tech.2011; 4(9): 1386-1388.
10. Mohit D, Bauskar, Prafulla Sonawane, Santosh Y, Nandedkar, Rajendra D. Wagh, Tanvir Shaikh, Vaibhav Jagtap. Development and Validation of Reverse Phase Liquid Chromatographic Methods for the Determination of Acebrophylline in Capsule Form. Research J. Pharm. and Tech.2011; 4(10): 1542-1546..
11. Kalyankar T.M, Kakde R.B. Reversed-Phase Liquid Chromatographic Method for Simultaneous Determination of Artesunate and Mefloquine in Pharmaceutical Preparations. Research J. Pharm. and Tech.2011; 4(10): 1563-1566.
12. Sudha T, Shanmugasundram P. Development and Validation of RP-HPLC and HPTLC Chromatographic Methods of Analysis for the Quantitative Estimation of Raltegravir Potassium in Pharmaceutical Dosage Form. Research J. Pharm. and Tech.2011; 4(11): 1746-1750.