INTRODUCTION:

Cancer is defined as a ‘group of diseases characterized by the uncontrolled growth and spread of abnormal cells’ and is one the deadliest diseases globally. Cancer represents the second most common cause of death in Europe and USA after cardiovascular diseases according to cancer facts and figure of 2016, a publication distributed by the American cancer society¹, and data extracted in October 2016 from euro stat-statistics explained web.

Albeit huge advances are being made against malignant growth, this infection stays a key general wellbeing concern and a colossal weight on European and American social orders². Every year the American culture gathers and aggregates the latest observation and the study of disease transmission information about malignant growth. In 2017, 1,688,780 new disease cases will rise and 600,920 malignant growth passings are anticipated to happen in United States³. As of late, masculine advances have been made in the improvement of surgeries, radiotherapy and chemotherapeutic agents⁴ including the instance of joining chemotherapy and agreement treatment with immunotherapy⁵.

Lenalidomide:

Lenalidomide is a derivative of thalidomide with better biological activity. Lenalidomide chemically it is 3-(4-Amino-1, 3-dihydro-1-oxo-2H-isoindol-2-yl)-2, 6-piperidinedione is represented in figure 1.

Figure 1: Chemical structure of Lenalidomide

The chemical formula is C₁₃H₁₃N₃O₃ and molecular weight is 259.261g/mol. Lenalidomide (LND) is an oral immune modulatory drug with anti-angiogenic and anti-neoplastic properties. It fundamentally takes after thalidomide however has an improved danger profile and progressively strong immune modulatory action^6,7. LND showed wonderful clinical movement in treatment of numerous myeloma malady^8-12. by means of a various pathways system^13-16. The system of activity of lenalidomide stays to be completely portrayed, anyway it has been exhibited that lenalidomide represses the outflow of cyclooxygenase-2 (COX-2), yet not COX-1, in vitro. In vivo it initiates tumor cell apoptosis legitimately and in a roundabout way by restraint of bone marrow stromal cell support, by hostile to angiogenic and against osteo clastogenic impacts, and by immune modulatory action.

Chromatographic Methods:

HPLC Methods:

Sadhana Raj put et al. (2019) reported 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. G.V. Krishna Mohan et al. (2018) reported Development and Validation of Stability-Indicating RP-HPLC Method for the Estimation of Lenalidomide and its impurities in Oral Solid Dosage form.Veera venkata satyanaryana Reddy karri et al. (2017) detailed Ameliorating the antitumor action of lenalidomide utilizing PLGA nanoparticles for the treatment of numerous myeloma.Saddhana Raj put et al. (2017) detailed Estimation of lenalidomide in mass and its structure utilizing uv spectrophotometric and RP-HPLC techniques. Nourah z.Alzoman et al. (2016) detailed A Validated Stability-Indicating and Stereo specific RP-HPLC Method for the assurance of Lenalidomide enantiomers in Bulk Form and Capsules. Beatriz guglieri-lopez et al (2016) announced A Wide Linearity Range Method for the Determination of Lenalidomide in Plasma by High-Performance Liquid Chromatography: Application to Pharmacokinetic Studies. Mohammed ishaq et al. (2015) revealed New RP HPLC technique improvement and approval for the estimation of test and related substances of the lenalidomide in mass and its structure. Janardhan Reddy et al. (2012) announced Development of A Rapid and Sensitive HPLC Assay Method for Lenalidomide Capsules and its Related Substances. Rajendra Prasad et al. (2011) announced Estimation of Lenalidomide in Capsules Dosage Forms by RP-HPLC. Sravanan et al. (2007) revealed Development of a HPLC Assay Method for Lenalidomide. Morita TO et al. (2016) revealed Stability of lenalidomide suspension after arrangement by a basic suspension technique for enteral cylinder organization. The HPLC conditions are given in table 1.

Table 1: Lenalidomide HPLC Reported Methods

S.No.	Sample matrix	Column	Mobile phase	Detector	References
1	API	C-18	Ammonium Acetate buffer: Methanol (85:15v/v)	PDA 250 nm	17
2	Capsule	C-18	Potassium dihydrogen orthophosphate anhydrous buffer and methanol(90:10v/v) and (35:65 v/v)	PDA 210 nm	18
3	Nanoparticles	C-18	pH 4.2 20mM potassium dihydrogen phosphate:ACN(86:14 v/v )	PDA 220 nm	19
4	API and Capsule	C-18	Acetate buffer 20mM,pH5:Methanol(85:15 v/v)	UV 250 nm	20
5	API and Capsule	LUX 5U cellulose-2 chiral	Methanol: glacial acetic acid:Triethyl amine(100:0.01:0.01)	UV 220 nm	21
6	Plasma	C-18	Phosphate pH 3.2 buffer:ACN(85:15v/v)	UV 311nm	22
7	API and Capsule	Waters X-terra RP 18	Waters X-terra RP 18 (250mm X 4.6mm X 5μ)	UV 210nm	23
8	Capsule	C-18	85:15 v/v ratio of mobile phases A (mixture of phosphoric acid buffer and 1-octane sulphonic acid sodium salt) and B(55: 45 v/v ratio of methanol and ACN)	UV 254 nm	24
9	Capsule	Xterra RP C-18	0.03M KH2PO4 in water at pH: 3.2, adjusted with Acetonitrile (30:70).	PDA 218 nm	25
10	API	Intersil ODS 3V	Buffer:ACN: methanol (80:8:12 v/v/v)	UV 254 nm	26
11	suspension	C-18	10 mM ammonium acetate (pH 7.0)/acetonitrile	UV 254 nm	27

UPLC Methods:

Hadir M.Maher estimated time of arrival al. (2015) detailed Simultaneous assurance of dexamethasone and lenalidomide in rodent plasma by strong stage extraction and ultra-execution fluid chromatography-pair mass spectrometry: application to pharmacokinetic considers. Tanveer A wani et al. (2013) announced Development and approval of ultra-execution fluid chromatographic strategy with pair mass spectrometry for assurance of lenalidomide in bunny and human plasma. The UPLC conditions are given in table 2.

Table 2: UPLC Reported Methods

S.No

Sample matrix

Column

Mobile phase

Detector

References

Rat plasma

C18

Formic acid in water:formicacid in ACN(20:80v/v)

Rat plasma and Human plasma

UPLC BEH C18

ACN:water:formic acid(65:35:0.1 v/v/v)

LC-MS Methods:

Premanand Ranganath et al. (2018) announced Development and approval of Lenalidomide in human plasma by LC-MS/MS. Chang shu et al. (2016) detailed LC-MS/MS strategy for synchronous assurance of thalidomide, lenalidomide, cyclophosphamide, bortezomib, dexamethasone and adriamycin in serum of numerous myeloma patients. Sridhar Vera Raghavan et al. (2015) detailed Simultaneous evaluation of lenalidomide, ibrutinib and its dynamic metabolite PCI-45227 in rodent plasma by LC-MS/MS: Application to a pharmacokinetic study.

Krishna pocha et al. (2015) announced Rapid assurance of lenalidomide in rodent plasma by a ultra presentation fluid chromatography/couple mass spectrometric technique. Sridhar Vera Raghavan et al. (2014) announced Simultaneous evaluation of idelalisib, fludarabine and lenalidomide in rodent plasma by utilizing superior fluid chromatography combined with warmed electro shower ionization pair mass spectrometry. Gopinath et al. (2011) detailed Development and approval of a Rapid and touchy examine for concurrent measurement of lenalidomide and dexamethasone in human plasma by fluid chromatography coupled to pair mass-spectrometry. Quing Liu et al. (2008) revealed Development and Validation of a Highly Sensitive Liquid Chromatography/Mass Spectrometry Method for Simultaneous Quantification of Lenalidomide and Flavopiridol in Human Plasma. The LC-MS conditions are given in table 3.

Electrophoresis Methods:

Yilunyan et al. (2015) detailed Lenalidomide a blockbuster medicate for the treatment of numerous myeloma: semi preparative partition through supercritical liquid chromatography and vibration round dichroism spectroscopy. Zoltan-istvanszabo et al. (2017) reported Chiral partition of lenalidomide by fluid chromatography on polysaccharide-type stationary stages and by fine electrophoresis utilizing cyclodextrin selectors.Darwish et al. (2013) announced Stability-demonstrating narrow electrophoresis technique with photodiode exhibit indicator for assurance of lenalidomide in pharmaceutical arrangement. Sarah Walz et al. (2015) revealed Investigation of the enantiomerization hindrances of the phthalimidone subsidiaries EM12 and lenalidomide by powerful electro active chromatography. The Electrophoresis conditions are given in table 4.

Table 3: Lenalidomide LC-MS/MS Reported Methods

S.No.	Sample matrix	Column	Mobile phase	Detector	References
1	Human plasma	C18	Formic acid: methanol(90:10)	MS	30
2	Human serum	Water X bridge BEH C18	Formic acid aqueous solution:ACN	MS	31
3	Rat plasma	ODS	ACN:0.1% Formic acid buffer	MS	32
4	Rat plasma	Acquity BEH C18	Buffer:ACN:Formic acid(30:70:0.1 v/v/v)	MS	33
5	Rat plasma	C18	Methanol:0.1% formic acid buffer(70:30 v/v)	MS	34
6	Human plasma	X terra C-18	Methanol: formic acid(90:10 v/v)	MS	35
7	Human plasma	C-18	ACN and water each with 0.1% formic acid	MS	36

Palbociclib:

Palbociclib chemically it is6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(1-piperazinyl)-2-pyridinyl] amino} pyrido [2, 3- d] pyrimidin-7(8H)-one. It is shown to in figure 2.

Figure 2: Chemical structure of Palbociclib

The compound recipe is C₂₄H₂₉N₇O₂and the atomic weight is 259.26g/mol. Palbociclib is another medication utilized for the treatment of bosom cancer.US Food and Drug Administration (FDA) has given endorsement for Palbociclib. FDA has shown that palbociclib must be utilized alongside Letrozole which is an aromatase inhibitor. Palbociclib additionally goes about as an inhibitor of cyclin-subordinate kinases 4 and 6, which are associated with advancing the development of malignant growth cells⁴¹. Dange et al. have built up a fluid chromatographic technique⁴² for the synchronous assurance of palbociclib to letrozole and Song et al. built up a turned around stage elite fluid chromatography (RP-HPLC) technique for the evaluation of palbociclib in capsules⁴³. Palbociclib is a CDK4/6 inhibitor endorsed for metastatic estrogen receptor-positive bosom malignancy.

Chromatographic techniques:

Mohamed hefnaway et al. (2019) revealed Evaluation of the Pharmacokinetics of the Simultaneous Quantification of Letrozole and Palbociclib in Rat Plasma by a Developed and Validated HPLC by PDA. Alejandra Martinez-Chavez et al. (2019) revealed Development and approval of a bioanalytical technique for the measurement of the CDK4/6 inhibitors abemaciclib, palbociclib, and ribociclib in human and mouse lattices utilizing fluid chromatography-pair mass spectrometry. Mohamed hefnaway et al. (2019) announced Development and approval of an UHPLC-MS/MS technique for concurrent assurance of palbociclib, letrozole and its metabolite carbinol in rodent plasma and pharmacokinetic study application. David Paul et al. (2019) detailed Pharmacokinetic connection of investigation of novel mix of palbociclib and sorafenib for hepatocellular carcinoma in SD rodents. David Paul et al. (2018) announced An appraisal of the effect of green tea extricate on palbociclib pharmacokinetics utilizing an approved UHPLC-QTOF-MS technique. Srinivasa Rao et al. (2018) detailed Determination of palbociclib in human plasma utilizing superior fluid chromatography - bright location. Pramadvara kallepalli et al. (2018) revealed new solidness showing fluid chromatographic technique for assurance of palbociclib.Yuvraj dange et al. (2017) revealed Optimization and approval of RP-HPLC strategy for synchronous estimation of palbociclib and letrozole. The chromatographic conditions are given in table 5.

Table 5: Palbociclib Reported Methods

S. No.	Sample matrix	Column	Mobile phase	Detector	References
1	Rat plasma	C-18	Methanol:30mM,Ph 5.5 ammonium acetate (60:40v/v)	PDA 240nm	44
2	Human and mouse matrices	C-18	10mM ammonium bicarbonate in water:10mM ammonium bicarbonate in water-methanol	MS	45
3	Rat plasma	UPLC BEH C-18	Methanol: water containing 0.1% acetic acid pH 4.5 (55:45 v/v)	MS	46
4	API	C-18	0.1% formic acid:ACN	MS	47
5	Green tea extract	Acquity UPLC BEH C-18	0.1% formic acid:ACN	MS	48
6	Human plasma	Agilent zorax C-18	ACN:0.1% triethyl amine pH 3.3 adjusted with ortho phosphoric acid	UV 266 nm	49
7	API	Inertsil ODS-3V	Ammonium acetate: Acetonitrile(32:68)v/v	PDA 263 nm	50
8	API	Intersil C-18	0.02M sodium dihydrogen phosphate buffer pH 5.5:ACN:methanol (80:10:10 v/v/v)	PDA 254 nm	51

CONCLUSION:

A systematic review of various analytical methods for determination of lenalidomide and palbociclib single and combined pharmaceutical dosage forms. The methods reported are time consuming and complex. These methods provide analysis time and more separation than other techniques. The study revealed that HPLC and LC-MS/MS methods are predominant for the estimation of lenalidomide and palbociclib pharmaceutical formulations and biological samples. There is a great scope for the method development of newer analytical methods for latest drugs such as lenalidomide and palbociclib.

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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.

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Received on 09.06.2020 Modified on 11.08.2020

Research J. Pharm. and Tech 2021; 14(10): 5443-5448.

DOI: 10.52711/0974-360X.2021.00949

S. No	Sample matrix	Column	Mobile phase	References
1	API	Amylose tris (3,5-dimethyl phenyl carbamate)-coated and the single urea bound β-cyclo dextrins chiral stationary phase	SCF,Recovery of two enantiomers 81.7% and 79.5%	37
2	API	chiralcel OJ column	30mM sulfobutylether-β-cyclodextrin,30mM phosphate buffer pH6.5	38
3	Capsule	Deactivated fused silica capillary electrophoresis(152cmeffective length X 75μm)	phosphate buffer (20mM,pH 7.1):Methanol (90:10 v/v	39
4	API	chiralcel OJ column	50 mM aqueous disodium hydrogen phosphate buffer at pH 8 and 50 mM aqueous sodium tetra borate buffer at pH 9.3	40