Abstract Article


New cost effective RP-HPLC method development and evaluation for quantitative estimation of Pitavastatin in pharmaceutical formulation

Ajeet Patel*, Pushpendra Soni, Neha Yadav, Lavakesh Kumar Omray

ONLINE ISSN : 2456-8244



A simple, sensitive, reliable and rapid reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for the determination of pitavastatin in bulk and pharmaceutical dosage form. The chromatographic system consisted of waters (784), 515 binary Pump, data Ace with UV-Visible detector. Separation was achieved on the thermo C18 (250 x 4.60), 5 μ particle size column in isocratic mode at room temperature. The sample was introduced through an injector valve with a 20 μl, sample loop. 20mM KH2PO4 (pH-3.0 with OPA): Acetonitrile 20:80 (%, v/v), was used as mobile phase with flow rate of 1 ml/min. UV detection was performed at 250 nm. A calibration graph was plotted which showed a linearity range between5-25 μg/ml with the correlation coefficient of 0.997. The LOD was 0.095μg/ ml, while the LOQ was 0.271 μg/ml. Validation studies revealed the method is specific, rapid, reliable and reproducible. To study the validity of the method, recovery studies and repeatability studies were carried out using the same optimum conditions. The system suitability studies were also calculated which includes column efficiency, resolution, capacity factor and peak asymmetrical factor. Therefore the proposed method is reliable, rapid, precise and selective so may be used for the quantitative analysis of pitavastatin.


HPLC, Pitavastatin, Pharmaceutical dosage form, Method Validation



1. M. Soyka, C. Schuetz, and U. Preuss, Drugs in R & D, 3, 58–60 (2002) 2. Martindale: The Complete Drug Reference, 35th edn, Pharmaceutical Press, London, 2007, pp. 1234 3. Remington: The Science and Practice of Pharmacy, 21st edn, Lippincott Williams & Wilkins, New York, 2006, pp. 1368 4. L. Rosa and C. John, Amer. J. Cardiovasc. Drugs, 3, 271–281 (2003) 5. K. Kalinami, N. Takekoshi, and Y. Saito, Cardiovasc. Drug Rev., 21, 199– 215 (2003) 6. The Merck Index, 14th edn, Merck Research Laboratories, Division of Merck and Co. Inc., Whitehouse Station, NJ, 2006, pp. 1294–1295. 7. Krishna M.V. and Sankar D.G. Adaptation of colour reactions for spectrophotometric determination of pitavastatin calcium in bulk drugs and in pharmaceutical formulations. E-J. Chem., 2007, 4, 272-278. 8. Vadia N.H., Vandana P. and Bhalara H.N. Spectrophotometric Determination of Cefetamet pivoxil hydrochloride and Pitavastatin Calcium in Tablet Dosage Form. Indian J. Pharm. Sci., 2008, 70, 649- 651. 9. Satheesh N.K. and Baghyalakshmi J. Determination and Quantification of PitavastatinCalcium in Tablet Dosage Formulation by HPTLC Method. Anal. Lett., 2007, 40, 2625- 2632. 10. Hiral J.P., Bhanubhai N.S., Natvarlal J.P. and Bhavesh H.P. A Simple and Sensitive HPTLC method for Estimation of Pitavastatin Calcium in Tablet Dosage Form. J. Planar Chrom., 2008, 21, 267-270. 11. Kojima J., Fujino H., Yosimura M., Morikawa H. and Kimata H. Simultaneous Determination of NK- 104 and its lactone in Biological samples by Column-switching highperformance liquid chromatography with Ultraviolet detection. J. Chromatogr. B, 1999, 724, 173-180. 12. Ramakrishna N., Koteshwara M. and Vishwottam K. Chromatography– Mass Spectrometry Methods for the Quantitation of Statins in Biological samples. J. Pharm. Biomed. Anal., 2007, 44, 379- 387. 13. Nanjappan S.K., Narayanan N., Jayabalan N., Narayanan S. and Bagyalakshmi J. HPLC Determination of Pitavastatin Calcium in Pharmaceutical Dosage Form. Pharma. Ana. Acta, 2011, 2, 119. 14. Hiral J.P. and Bhanubhai N.S. HPLC Determination of Pitavastatin Calcium in Pharmaceutical Dosage. J. AOAC Int., 2009, 92, 158-64. 15. Ojha A., Guttikar S., Vayeda C. and Padh H. Determination of Pitavastatin from Human Plasma. Se Pu, 2007, 25, 715-718. 16. Pawel G., Giampietro V., Daniela V., Francesco D., Anna G. and Jadwiga M. Photo Stability of Pitavastatin-A Novel HMG-CoA reductase inhibitor. J. Pharm. Biomed. Anal., 2009, 50, 597- 601. 17. Hiral J.P. and Bhanubhai N.S. Stability Indicating High Performance Liquid Chromatographic Method for Determination of Pitavastatin Calcium In Tablet Dosage Form. Acta Chrom., 2011, 3, 81-94. 18. Antony R.G., Pannala R.R., Nimmakayala S. and Jadi S. Degradation Pathway for Pitavastatin Calcium by Validated Stability Indicating UPLC Method. American J. Ana. Chem., 2010, 2, 83-90. 19. Jian W.D., Kwon B.K., Hong H.Z., Kwang H.L. and Jae G.S. Determination of two HMG-CoA reductase inhibitors, Pravastatin and Pitavastatin, in Plasma samples using Liquid chromatography-Tandem Mass Spectrometry for Pharmaceutical study. Biomed. Chrom., 2008, 22, 131- 135. 20. Lei T., Yiling H., Youhong J., Lu H. and Yishi L. Development and Validation of a Liquid chromatography-Tandem Mass Spectrometric assay for Pitavastatin and its lactone in human plasma and Urine. J. Chrom. B, 2008, 865, 127- 132. 21. Hua L.V., Jian G.S., Guang J.W., Xiao Y.Z., Ying Z., Sheng H.G., Yan L. and Jie S. Determination of Pitavastatin in Human plasma via HPLC-ESIMS/ MS. Clin. Chimica Acta, 2007, 386, 25- 30. 22. Code Q2 (R1) -Text on Validation of Analytical Procedures: Text and Methodology Current Step 4 version, 2005, ICH Harmonised Tripartite Guideline.