Author(s): Punna Venkateshwarlu, Mehul M. Patel

Email(s): mehulpatel.ph@gmail.com

DOI: 10.52711/0974-360X.2021.00949   

Address: Punna Venkateshwarlu1, Mehul M. Patel*2
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.
*Corresponding Author

Published In:   Volume - 14,      Issue - 10,     Year - 2021


ABSTRACT:
This article reviews the various analytical methods reported so far in the literature for the determination of stability and impurity profile the lenalidomide and palbociclib anti cancer drugs in single or combination with other drugs in bulk, pharmaceutical dosage forms, biological fluids, stability indicating and impurity profiling methods. The analytical methods used for the estimation of lenalidomide and palbociclib anticancer drugs reviewed in this paper includes ultraviolet spectrophotometry,high performance liquid chromatography (HPLC) ,ultra performance liquid chromatography (UPLC) ,liquid chromatography-mass spectrometry (LC-MS) and electrophoresis. This review focus on the effect of all chromatographic parameters so as to provide as fast, reliable and cost effective methodology of testing. Method development is the process of proving that analytical method is acceptable for use to measure the concentration of active pharmaceutical ingredient in a specific compound dosage form which must be validated to provide reliable data for regulatory submissions. This reviewed is mainly on analytical method development and validation, stability indicating methods, simultaneous estimation methods and bioanalytical methods. The review covers the time period from 2007 to 2019 during which analytical methods including all types of spectrophotometric and chromatographic techniques were reported. The Review covers lenalidomide and palbociclib API and formulation analytical and bioanalytical methods.


Cite this article:
Punna Venkateshwarlu, Mehul M. Patel. A Review: Method Development Validation and Degradation Studies of some Anticancer Drugs. Research Journal of Pharmacy and Technology 2021; 14(10): 5443-8. doi: 10.52711/0974-360X.2021.00949

Cite(Electronic):
Punna Venkateshwarlu, Mehul M. Patel. A Review: Method Development Validation and Degradation Studies of some Anticancer Drugs. Research Journal of Pharmacy and Technology 2021; 14(10): 5443-8. doi: 10.52711/0974-360X.2021.00949   Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-10-67


REFERENCES:
1    American Cancer Society. Cancer Facts and Figures 2016; American Cancer Society: Atlanta, GA, USA, 2016.
2    Mudit M, El Sayed K.A. Cancer control potential of marine natural product scaffolds through inhibition of tumor cell migration and invasion. Drug Discov. Today 2016; 21:1745–1760.
3    Siegel R.L, Miller K.D, Jemal A. Cancer statistics, 2016. CA Cancer J. Clin. 2016; 66:7–30.
4    Mullard A. FDA approves first immunotherapy combo. Nat. Rev. Drug Discov. 2015; 14:561–584.
5    Nicolini A, Carpi A, Ferrari P,Biava P.M, Rossi G. Immunotherapy and hormone-therapy in metastatic breast cancer: A review and an update. Curr. Drug Targets 2016; 17:1127–1139.
6    Kastritis E, Dimopoulos MA. The evolving role of lenalidomide in the treatment of hematologic malignancies.Expert Opin Pharmacother 2007; 8:497–509.
7    Mitsiades CS, Mitsiades N: CC-5013 (Celgene). Curr Opin Investig Drugs 2004, 5:635–647.
8    Tariman JD. Lenalidomide: a new agent for patients with relapsed or refractory multiple myeloma. Clin J Oncol Nursing 2007; 11:569–574.
 9    Sonneveld P, Palumbo A. Lenalidomide: a new therapy for multiple myeloma. Cancer treatment reviews 2008;   34:283-291.
10    Shah SR, Tran TM. Lenalidomide in myelodysplastic syndrome and multiple myeloma. Drugs 2007, 67:1869–1881.
11    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.
12    Hideshima T, Richardson PG, Anderson KC. Current therapeutic uses of lenalidomide in multiple myeloma. Expert Opin Invest Drugs 2006; 15:171–179.
13    Corral LG, Haslett PA, Muller GW, Chen R, Wong LM, Ocampo CJ, Patterson RT, Stirling DI, KaplanG. Differential cytokine modulation and T cell activation by two distinct classes of thalidomide analogues that are potent inhibitors of TNF-alpha. J Immunol 1999; 163:380–386.
14    Anderson KC.Lenalidomide and thalidomide: mechanisms of action-similarities and differences. Seminars Hematol 2005; 42:S3–S8.
15    Richardson P, Anderson K.Immunomodulatory analogs of thalidomide: an emerging new therapy in myeloma. J Clin Oncol 2004; 22:3212–3214.
16    Verhelle D, Corral LG, Wong K, Mueller JH, Parseval LM, Pergakes KJ, Schafer PH, Chen R, Glezer E, Ferguson GD, Lopez-Girona A,Muller GW, Brady HA, Chan KWH.Lenalidomide and CC-4047 inhibit the proliferation of malignant B cells while expanding normal CD34+ progenitor cells. Cancer Res 2007; 67:746–755.
17    Sadhana rajput juhi saxena, Seema saroj, Priya virendraKumar shah. Development and Validation of an  Environmentally Benign and Robust Stability Indicating Assay Method for Lenalidomide Comprehensive Degradation Kinetics Study and Application of Synergistic Approach Involving Green Analytical Chemistry and Quality by Design Methodology. Indian journal of pharmaceutical education and research, 2019; 53:133-142.
18    Yilunyan,Junfan,Dong guo,Yuemeilin,Yecai lai,Taiwang,hao gao,Xinsheng yao and Weiguang zhang. Journal of separation science 2018; 41:3840-3847.
19    Premanand ranganathan, V.gunasekaran, Indrajeet singhvi and Mohammad javed ansari. Development and validation of Lenalidomide in human plasma by LC-MS/MS. Saudi journal of biological sciences 2018, 1-5.
20    Juhi saxena, Seema saroj and Sadhana raj put. Estimation of lenalidomide in bulk and its dosage form using uvspectrophotometric and RP-HPLC methods.Indo American journal of pharmaceutical research 2017;3:7938-7945.
21    Nourah z.Alzoman.A Validated Stability-Indicating and Stereo selective   RP-HPLC Method for the determination of Lenalidomide enantiomers in Bulk Form and Capsules. Journal of chromatographic science 2016; 54:730-735.
22    Beatriz guglieri-lopez, Alejandro perez-pitarch, Maria amparo Martinez-gomez, begona porta-oltra, Monica climente-marti and Matilde merino-sanjuan. A Wide Linearity Range Method for the Determination of Lenalidomide in Plasma by High-Performance Liquid Chromatography: Application to Pharmacokinetic Studies. Journal of laboratory automation 2016; 6:806-810.
23    B.Mohammad ishaq, S.Swetha, Hindustan Abdul ahad, Vanitha parkash. New RP HPLC method development and validation for the estimation of assay and related substances of the lenalidomide in bulk and dosage form. Indo American journal of pharmaceutical sciences 2015; 2:1173-1177.
24    Maheswara reddy,Janardhan reddy,Bhaskar reddy and Raveendra reddy, Development of A Rapid and Sensitive HPLC Assay Method for Lenalidomide Capsules and its Related Substances. Journal of chemistry 2012; 3:1165-1174.
 25    Ravi pratap pulla,B.S.Sastry,y.rajendra Prasad,R.Appala raju, Estimation of Lenalidomide in Capsules Dosage Forms by RP-HPLC.Journal of pharmacy research 2011;4:1199-1200.
26    G.saravanan, B.M.Rao, M.Ravikumar, M.V.Suryanarayana, N.Someswararao and P.V.R Acharyulu, Development of an HPLC Assay Method for Lenalidomide. Chromatographia 2007; 66:287-290.
27    Morita TO, Yamaguchi A, Kimura S, Fujii H, Endo K, Izumi K, Saito S, Minami H Stability of lenalidomide suspension after preparation by a simple suspension method for enteral tube administration. Journal of oncology Pharmacy Practice 2016; 4:579-583.
28    Hadir M. Maher, Nourah z.alzoman, Mona M.alsheri, hayal.aljohar, Shereen shenanta, Manal alossaimi and Norah o.abanmy. Simultaneous determination of dexamethasone and lenalidomide in rat plasma by solid phase extraction and ultra-performance liquid chromatography-tandem mass spectrometry: application to pharmacokinetic studies. RSC advances 2015; 119:97910-98723.
29    Muzaffar iqbal, Tanveer A wani, Nasir y khalil and Ibrahim A darwish. Development and validation of ultra-performance liquid chromatographic method with tandem mass spectrometry for determination of lenalidomide in rabbit and human plasma. Chemistry central journal 2013; 7:1-9.
30    Premanand ranganathan, V.gunasekaran, Indrajeet singhvi and Mohammad javed ansari: Development and validation of Lenalidomide in human plasma by LC-MS/MS. Saudi journal of biological sciences 2018, 1-5.
31    Chang shu,Tianmei zeng ,Shouhong gao, Tianyi xia, Lifeng huang, Fengzhang and Wansheng chen. LC-MS/MS method for simultaneous determination of thalidomide, lenalidomide, cyclophosphamide, bortezomib,dexamethasone and adriamycin in serum of multiple myeloma patients, 2016,1028:111-119.
32    Sridhar Vera raghavan, Satheesh manikandan thappali, Srikant viswanandha, Swaroop Kumar vakkalanka, Manivannan rangasamy and Babu govindarajulu. Simultaneous quantification of lenalidomide, ibrutinib and its active metabolite PCI-45227 in rat plasma by LC-MS/MS: Application to a pharmacokinetic study. Journal of pharmaceutical and biomedical analysis 2015; 107:151-158.
33    Krishna pocha and G.devala rao. Rapid determination of lenalidomide in rat plasma by an ultra performance liquid chromatography/tandem mass spectrometric method. Medicinal chemistry research 2015; 24:459-467.
34    Sridhar Vera raghavan,Satheesh ,Manikandan thappali,Srikant viswanandha,Santhosh Kumar nalla,Sandhya rani chennupati,Manikanta Kumar golla,Swaroop Kumar vakkalanka,Manivannan rangasamy. Simultaneous quantification of idelalisib, fludarabine and lenalidomide in rat plasma by using high-performance liquid chromatography coupled with heated electro spray ionization tandem mass spectrometry. Journal of chromatography B 2014; 949:63-69.
35    Gopinath, Shanmugam, S.Kumar, Ramadass, Alexander, Sekar, Danbal, Palanisamy. Development and validation of a Rapid and sensitive assay for simultaneous quantification of lenalidomide and dexamethasone in human plasma by liquid chromatography coupled to tandem mass-spectrometry. Current pharmaceutical analysis 2011; 7:240-247.
36    Liu Q, Farley KL, Johnson AJ, Muthusamy N, Hofmeister CC, Blum KA, Schaaf LJ, Grever MR, Byrd JC, Dalton JT and Phelps MA:Development and validation of a highly sensitive liquid chromatography/mass spectrometry method for simultaneous quantification of lenalidomide and flavopiridol in human plasma. Ther Drug Monit. 2008; 5:620–627.
37    Yilunyan, Junfan, Dong guo, Yuemeilin, Yecai lai,Taiwang,hao gao,Xinsheng yao and Weiguang zhang: Lenalidomide, a blockbuster drug for the treatment of multiple myeloma: Semipreparative separation through supercritical fluid chromatography and vibrational circular dichroism spectroscopy. Journal of separation science 2018; 41:3840-3847.
38    Zoltan-istvan szabo,Mohammadhassan,Forough bakhshfasaei,Reka gal,Peter Horvath,Balazs komjati,Bela noszal,gergo toth.Chiral separation of lenalidomide by liquid chromatography on polysaccharide-type stationary phases and by capillary electrophoresis using cyclodextrin selectors. Journal of separation science 2018; 41:1414-1423.
39    M.M.alshehrt, H.M.maher, N.Z.Alzoman, M.A.Sultan, I.A.Darwish.Stability indicating capillary electrophoresis method with photodiode array detector for determination of lenalidomide in pharmaceutical preparation. Digest journal of nanomaterials and biostructures 2013; 8:855-867.
40    Walz, Sylvia,Mareike Franz and Frank Rominger.Investigation of the enantiomerization barriers of the phthalimidone derivatives EM12 and lenalidomide by dynamic electro kinetic chromatography.Electrophorosis 2015;5:641-830.
41    Tamura K, Mukai H, Naito Y, Yonemori K, Kodaira M, Tanabe Y. Phase I study of palbociclib, a cyclin-dependent    kinase 4/6 inhibitor, in Japanese patients. Cancer Sci 2016; 107:755-63.
42    Dange Y, Bhinge S, Salunkhe V. Optimization and validation of RP-HPLC method for simultaneous estimation of palbociclib and letrozole. Toxicol Mech Methods 2018; 28:187-194.
43    Song WJ, Wang Z, Qiu F, Li W. Content determination of Palbociclib capsules. Chin J New Drugs 2017; 26:2468-2471
44    Mona al-sheri, Mohamed hefnawy, Hatem abuelizz and Adeeba alzamil. Evaluation of the Pharmacokinetics of the Simultaneous Quantification of Letrozole and Palbociclib in Rat Plasma by a Developed and Validated HPLC–PDA.Acta chromatographica 2019;1-9.  
45    Alejandra Martínez-Chávez, Hilde Rosing, Michel Hillebrand, Matthijs Tibben, Alfred H. Schinkel, and Jos H. Beijnen. Development and validation of a bioanalytical method for the quantification of the CDK4/6 inhibitors abemaciclib, palbociclib, and ribociclib in human and mouse matrices using liquid chromatography-tandem mass spectrometryAnal Bioanal Chem. 2019; 411(20): 5331–5345
46    Mona al-sheri, Mohamed hefnawy, Hatem abuelizz and Adeeba alzamil, Mostafa Mohammed, Nawaf al saif, Abdul rahman al mehizia, Hamad alkahtani and Mohammed abouna ssif. Development and validation of an UHPLC-MS/MS method for simultaneous determination of palbociclib, letrozole and its metabolite carbinol in rat plasma and pharmacokinetic study application. Arabian journal of chemistry 2019; 2:4024-4034.
 47    David paul, Patheparapu chandrakala, Shruti surendran and Nanjappan satheesh kumar. Pharmacokinetic interaction of study of novel combination of palbociclib and sorafenib for hepatocellular carcinoma in SD rats. Journal of chromatography B 2019; 1108:25-31.
48    David paul, Patheparapu chandrakala, Shruti surendran and Nanjappan satheesh Kumar. An assessment of the impact of green tea extract on palbociclib pharmacokinetics using a validated UHPLC-QTOF-MS method. Biomedical chromatography 2018; 4:4469.
49.    R. B. Nalanda, A. Srinivasa Rao and D. Gowri Sankar. Determination of palbociclib in human plasma using high performance liquid chromatography - ultraviolet detection. International journal of pharmaceutical sciences and research 2018; 9:3883-3888.
50    Pramadvara Kallepalli and Mukthinuthalapati Mathrusri Annapurna. New stability indicating liquid chromatographic method for determination of palbociclib. International Journal of Green Pharmacy 2018; 1:270-275.
51    Yuvaraj dange, Somanath Bhinge and Vijay salunkhe. Optimization and validation of RP-HPLC method for simultaneous estimation of palbociclib and letrozole. Toxicology Mechanisms and Methods 2017; 28:187-194.

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