Determination of Pitavastatin Calcium by Analytical Spectrophotometry


  • Saad Antakli Department of Chemistry, Faculty of Science, University of Aleppo, Syria
  • Leon Nejem Department of Chemistry, Faculty of Science, University of Aleppo, Syria
  • Ahmad Kullah Department of Chemistry, Faculty of Science, University of Aleppo, Syria



Spectrophotometric, Pitavastatin calcium, Bromocresol purple


Simple and rapid spectrophotometric method for the quantitative analysis of Pitavastatin calcium (PTV) in raw material and tablets pharmaceutical formulation has been described. The method is based on the formation of yellow ion-pair complex between Pitavastatin calcium and Bromocresol purple (BCP) in chloroform medium.

Different parameters affecting the reaction such as: effect of solvents, stability, reagent concentration, correlation ratio, etc. were optimized. The formed complex was quantified spectrophotometrically at absorption maximum 405 nm. Linearity range was 2.20 - 35.23 µg/mL, regression analysis showed a good correlation coefficient R2 = 0.9991. The limit of detection (LOD) and limit of quantification (LOQ) were to be 0.367 µg/mL and 1.112 µg/mL respectively. The average percent recovery was found to be (100.62 – 101.14) % for Pitavastatin Calcium. This study was applied on Syrian pharmaceutical trademark: (PAVACRIUM 4 & Londalop). The method was successfully applied for the determination of Pitavastatin calcium in tablets pharmaceutical formulation.

The proposed method is simple, direct, sensitive and do not require any extraction process. Thus, this method could be readily applicable for the quality control and routine analysis.


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S. Pitavastatin Approved for Treatment of Primary Hypercholesterolemia and Combined Dyslipidemia, Vascular Health and Risk Management. 2010:6, 997–1005.

Yasushi S, Nobuhiro Y, Tamio T, Hiroshige I, Yoshiya H, Noriaki N, Hiroshi M, Motoo T, Jun S, and Nobuya O. Clinical Efficacy of Pitavastatin, a New 3-Hydroxy-3-methylglutaryl Coenzyme A Reductase Inhibitor in Patients with Hyperlipidemia, Arzneim.- Forsch./Drug Res. 52, No. 4, 251−255 (2002).

MUKHTAR J. REID, J. Pitavastatin, Blackwell Publishing International Journal Clin Pract, February 2005, 59, 2, 239–252.

Toshio H, Koutaro Y, Yasushi S, Akihisa I. Pitavastatin: Efficacy and Safety In Intensive Lipid Lowering, Pharmacother. (2007) 8(14) .

Jun Pankaj K, Bharti M, Satbir S. Pitavastatin: A Potent Drug, International Journal of Pharma Research and Health Sciences.2018;6 (1):2070-74.

Marwa K, Jamal L. Validated Kinetic Spectrophotometric Determination of Pitavastatin Calcium Using Acidic Permanganate Oxidation, Int J Pharm Pharm Sci, Vol 12, Issue 3, 28-33.

Niranjani S, Venkatachalam K. Method Development and Validation of Pitavastatin Calcium and its Degradation Behavior Under Varied Stress Conditions by UV Spectrophotometric Methods, Dhaka Univ. J. Pharm. Sci. 18(2): 159-169, 2019 (December).

Vadia N, Vandana P, Bhalara H. Spectrophotometric Determination of Cefetamet Pivoxil Hydrochloride and Pitavastatin Calcium in Tablet Dosage form, Indian Journal of Pharmaceutical Sciences.

Marothu V, Dannana G, Sankar. Adaptation of Color Reactions for Spectrophotometric Determination of Pitavastatin Calcium in Bulk Drugs and in Pharmaceutical Formulations Journal of Chemistry, Vol. 4, No.2, pp 272-278, April 2007.

Gamze E, Sena C, GLAR A, Arma G, Sıdıka E. Spectrophotometric Determination of 3-Hydroxy-3-Methylglutaryl Coenzyme-A Reductase Inhibitors in Pharmaceutical Preparations, Turk J Chem (2013) 37: 171 – 181.

Ramzia I, El-Bagary, Ehab F, ElKady M. Spectrofluorometric Determination of Certain Antihyperlipidemic Agents in Bulk and Pharmaceutical Preparations, Hindawi Publishing Corporation Spectroscopy: An International Journal Volume 27 (2012), Issue 2, Pages 83–92.

Ashok H. Akabari , Dinesh R. Shah , Shailesh A. Shah, Bhanubhai N. Suhagia, Kinetic Determinations of Pitavastatin Calcium by Stability Indicating HPTLC Method, Journal of Liquid Chromatography and Related Technologies, 38: 521–531, 2015.

Mrinalini C, Anuradha R. Stability Indicating HPTLC Method for the Estimation of Pitavastatin Calcium in presence of Acid Induced Degradation Product, International Journal of ChemTech Research. 2014,6(5),pp 2824-283.

Nanjappan S , Narayanan N, Jayabalan N, Narayanan S. HPLC Determination of Pitavastatin Calcium in Pharmaceutical Dosage Forms, Pharm Anal Acta 2:119.

Panchal H, Suhagia B. Stability-Indicating Liquid Chromatographic Method for Analysis of Pitavastatin Calcium in Tablet Dosage Forms, Acta Chromatographica 23(2011)1, 81–94.

Bozhanov S, Maslarska V. Spectroscopic and High-Performance Liquid Chromatography Methods for Determination of Statins, Pharmacia, vol. 63, No. 2/2016.

Hariram B, Kumar R, Anireddy J, Dama V, Kalyanaraman L, Katkam S. Ultra‑High Performance Method on Superficially Porous Stationary Phase for the Determination of Related Substances in Pitavastatin Calcium by HPL, Springer-Verlag Berlin Heidelberg 2015.

Tirumala K, Gautam S, Gangadhar J, Jayajeevitha M, Prakask V. RP-HPLC Assay for Estimation of Pitavastatin in Bulk and Pharmaceutical Dosage Forms, International Journal of Pharmaceutical Scienes and Nanotechnology. Vol 7; Issue 1. January – March 2014.

Vinodkumar R, Girish J, Ashim S, Girish S, Vijaykumar S. Development and Validation of RP-HPLC Method for Pitavastatin Calcium in Bulk and Formulation Using Experimental Design, Journal of Applied Pharmaceutical Science Vol. 9(10), pp 075-083, October, 2019.

Sujatha K, Seshagir N. A New Validated Stability-Indicating RP-HPLC Method for the Estimation of Pitavastatin in Tablet Dosage Forms. Pharmacy and analytical research vol-3(1) 2014 (67- 74).

Xiemin Q, Ding L, Aidomg W, Zhou N, Xiaolang D, Shailendra S. Simple LC-MS/MS Methods for Simultaneous Determination of Pitavastatin and its Lactone Metabolite in Human Plasma and Urine Involving A Procedure for Inhibiting the Conversion of Pitavastatin Lactone to Pitavastatin In Plasma and its Application to A Pharmacokinetic Study, Journal of Pharmaceutical and Biomedical Analysis 72 (2013) 8-15.

Tengrui Y, Qian L, Hui Z, Lirong Z, Hui L, Miao L, Meilan C, Wengang R. Lcems/MS Assay For Pitavastatin In Human Plasma and Subsequent Application To A Clinical Study In Healthy Chinese Volunteers, asian journal of pharmaceutical sciences 9 (2014) 348e355.

Kudige N, Kanakapura B, Madihalli S. Simple and Selective Spectrophotometric Determination of Ofloxacin in Pharmaceutical Formulations Using Two Sulphonphthalein Acid Dyes. Hindawi Publishing Corporation, 2013.

Amina A, Goudab A, El-Sheikh R, Zahran F. Spectrophotometric Determination of Gatifloxacin in Pure Form and in Pharmaceutical Formulation. Spectrochimica Acta Part A. 2007; (67): 1306–1312.

Britton H.T.S., Hydrogen Ions, fourth ed., Chapman and Hall, 1952.

Pharmacopeia USP34 NF 29 2011.




How to Cite

Antakli, S. ., Nejem, L. ., & Kullah, A. . (2021). Determination of Pitavastatin Calcium by Analytical Spectrophotometry. JOURNAL OF ADVANCES IN CHEMISTRY, 18, 30–39.




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