Volume : 13, Issue : 04, April – 2026
Title:
NEW STABILITY INDICATING METHOD DEVELOPMENT, VALIDATION OF PALBOCICLIB BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FROM ACTIVE PHARMACEUTICAL INGREDIENT AND DOSAGE FORMULATION
Authors :
Meganthiya D, R. Kanmani, Dr.P.D.Gokulan., Dr. K. L. Senthil Kumar *
Abstract :
A Simple, sensitive, specific, and precise RP-HPLC method for the Determination of Palbociclib in API and pharmaceutical dosage form. Chromatogram was run through Inertsil 150 x 3.8 mm, 5 m. Mobile phase containing Buffer 100% (6.0 gm of Sodium Phosphate Monobasic and 12.0gm Sodium Chloride) and pH adjusted with OPA to 2.6 and pumped through column at a flow rate of 0.6ml/min. Buffer used in this method was sodium phosphate. Temperature was maintained at 30°C. Optimized wavelength selected was 290.0nm. Retention time of Palbociclib was found to be 2.425 min. %RSD of the Palbociclib were and found to be 0.2. %RSD of Method precision of Palbociclib was found to be 0.3.
%Recovery was obtained as 100.51% for Palbociclib. LOD, LOQ values obtained from regression equation of Palbociclib were 0.15, 0.46. Regression equation of Palbociclib is y = 7641.9x + 645.29. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.
Key Words: Palbociclib, RP-HPLC, Validation
Cite This Article:
Please cite this article in press Meganthiya D et al., New Stability Indicating Method Development, Validation Of Palbociclib By Reverse Phase High Performance Liquid Chromatography From Active Pharmaceutical Ingredient And Dosage Formulation, Indo Am. J. P. Sci, 2026; 13(04).
REFERENCES:
1. Hearn M.T.W. Ion-pair Chromatography on normal and Reversed-phase systems. Adv. Chromatogr. 1980; 18: 59–100.
2. Bergh J. J., Breytenbach, J. C. Stability-indicating High-performance Liquid- chromatographic Analysis of Trimethoprim in Pharmaceuticals. J. Chromatogr. 1987; 387: 528-531.
3. Principles and Methods. In: Amesham Biosciences of Reversed Phase Chromatography. 1999;6-8.
4. Types of HPLC. NEW/HPLC_Book/Introduction/int_t yps.html. (Accessed Feb 12, 2017)
5. Hearn, M.T. Ion-pair chromatography on normal and reversed phase systems. Advances in Chromatography. 1980;18:59-100.
6. Malviya, R.; Bansal, V.; Pal, O.P.; Sharma, P.K. High Performance liquid chromatography: a short review. J Global Pharma Technol 2010;2(5):22-6.
7. Sneha, Lakshmi. R.P. A Review on Chromatography with High Performance Liquid Chromatography (HPLC) and its Functions. Research and Reviews: J Pharml Analysis 2015;4(1).
8. McCown, S.M.; Southern, D.; Morrison, B.E. Solvent Properties and their effects on gradient elution high-performance liquid chromatography: III. Experimental findings For water and acetonitrile. J Chromatography A 1986;352:493-509.
9. How Does High Performance Liquid Chromatography Work .
10. Harmita, et al. Optimation and validation of analytical method of cotrimoxazole in tablet and plasma in vitro by High performance liquid chromatography. J Bioanal Biomed. 2012;4:26-29.
11. Christain GD, Analytical Chemistry, 6th Edn.USA: John Wiley & Sons Inc, (2001).Mrs. S. Durga Mounika, RPHPLC Method Development and Validation for simultaneous Estimation of paracetamol and alprazolam in bulk and pharmaceutical.
12. How do I develop an HPLC method.
13. Separations Solutions: Mobile Phase pH, U.D. Neue, American Laboratory, March 1999, p. 60.
14. Nledner W, Karsten M, Stelner F, Swart R. Automating Method Development with an HPLC System Optimized for Scouting of Columns, Eluents and Other Method Parameters. Pittcon presentation; 2008.
15. International Conference on Harmonization (ICH), Validation of analytical methods definitions and terminology, ICH Q2 A, 1994.
16. International Conference on Harmonization (ICH), Validation of analytical methods: methodology, ICH Q2 B, 1996.
17. EURACHEM, The Fitness for Purpose of Analytical Methods—A Laboratory Guide to Method Validation and Related Topics, 1998.
18. Lalit VS, Bhagwat NP, Sharad VU, Pradeep kumar VW and Laxman HS Bioanalytical Method Validation and Its Pharmaceutical Application- A Review. Pharm Anal Acta 2014, 5:3.
19. Thompson M, Ellison SLR, Wood R, Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC technical report). Pure Appl. Chem 2002;74: 835–855.
20. Anhang C: Anforderungen an die Durchfu¨ hrung von Analysen, Validierung. Toxi chem Krimtech 2004;74:146– 154.