Author(s): Saad Antakli, Leon Nejem, Ahmad Kullah

Email(s): antakli@scs-net.org

DOI: 10.5958/0974-360X.2021.00129.3   

Address: Saad Antakli, Leon Nejem, Ahmad Kullah
Department of Chemistry, Faculty of Science, University of Aleppo, Syria.
*Corresponding Author

Published In:   Volume - 14,      Issue - 2,     Year - 2021


ABSTRACT:
Simple and rapid spectrophotometric method for the quantitative analysis of Pravastatin sodium (PVS) in raw material and tablets pharmaceutical formulation has been described. The method is based on the formation of yellow ion-pair complex between Pravastatin sodium and Bromocresol purple in Acetonitrile medium. Different parameters affecting the reaction such as: effect of solvents, time, reagent concentration, correlation ratio, etc. were optimized. The formed complex was quantified spectrophotometrically at absorption maximum at 389nm. Linearity range was 2.23 – 26.79µg/mL, regression analysis showed a good correlation coefficient R2 = 0.9997. The limit of detection (LOD) and limit of quantification (LOQ) were to be 0.158µg/mL and 0.479µg/mL respectively. The average percent recovery was found to be (99.16 - 100.00)% for Pravastatin sodium. This study was applied on Syrian pharmaceutical trademark: (PRAVASTATIN-ELSaad 20). The method was successfully applied for the determination of pravastatin sodium 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.


Cite this article:
Saad Antakli, Leon Nejem, Ahmad Kullah. Determination of Pravastatin Sodium by analytical Spectrophotometry. Research J. Pharm. and Tech. 2021; 14(2):741-746. doi: 10.5958/0974-360X.2021.00129.3


REFERENCES:
1.    Lennernäs H, Fager G. Pharmacodynamics and pharmacokinetics of the HMG-CoA reductase inhibitors. Clin. Pharmacokinet. 1997; 32: 403-425.
2.    Hatanaka T. Clinical pharmacokinetics of pravastatin: mechanisms of pharmacokinetic events. Clin. Pharmacokinet. 2000; 39: 397-412.
3.    Haria M, McTavish D, Pravastatin. A reappraisal of its pharmacological properties and clinical effectiveness in the management of coronary heart disease. Drugs. 1997; 53: 299-336.
4.    The British Pharmacopeia (2007).
5.    Kalvikkarasi S, Vaidhyalingam V, Niraimathi V and Ajithadas A. Spectrophotometric Determination of Pravastatin Sodium in Pharmaceutical Oral Solid Dosage Forms. Asian J. Chem. 2009; 21:1648-1650.
6.    Onal A, Sagirli O. Development of a selective LC method for the determination of pravastatin sodium. Chromatographia. 2006; 64(3/4):157-162.
7.    Pasha M K, Muzeeb S, Basha S J, Shashikumar D. Mullangi R. Srinivas N R. Analysis of five HMG-CoA reductase inhibitors- atorvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin: pharmacological, pharmacokinetic and analytical overview and development of a new method for use in pharmaceutical formulations analysis and in vitro metabolism studies. Biomedical Chromatography. 2006; 20(3): 282-293.
8.    Ashour S, Nakshbandi H, Omar S. Quantitative Determination of Pravastatin in Pharmaceutical Dosage Forms by High-Performance Liquid Chromatography with Ultraviolet Detection. International Journal of Biomedical Science. 2008; 4(2): 135-139.
9.    Campos M, Mendoza E, Alberto J. Development of a Selective Extraction Method for Pravastatin Quantification in Tablets using HPLC with Ultraviolet Detection. J. Liq. Chromatogr. Relat. Technol. 2008; 31(1-4): 619-623.
10.    Gomes F P, Garcia P L, Alves J M, Singh A K, Rosa E, Maria K, Maria Ines Rocha Miritello Santoro. Development and Validation of Stability Indicating HPLC Methods for Quantitative Determination of Pravastatin, Fluvastatin, Atorvastatin, and Rosuvastatin in Pharmaceuticals. Analytical Letters. 2009; 42(12): 1784-1804.
11.    Kircali K, Tunçel M, Aboul-Enein H Y. Determination of pravastatin in tablets by capillary electrophoresis. Farmaco. 2004; 59(3): 241-244
12.    Nigovic B and Vegar I. Capillary Electrophoresis Determination of Pravastatin and Separation of its Degradation Products. Croatica Chemica Acta. 2008; 81(4): 615-622.
13.    Kocijan A, Grahek R, Bastarda A, Zupancic K L. Fast analysis of pravastatin in production media, J. Chromatogr. B. 2005; 822 (1-2); 311-315. .
14.    Chaudhari B G, Patel N M, Shah P B. Determination of simvastatin, pravastatin sodium and rosuvastatin calcium in tablet dosage forms by HPTLC. Indian J Pharm Sci. 2007; 69(1): 130-132.
15.    Nigovic B. Electrochemical properties and square-wave voltammetric determination of pravastatin. Analytical and Bioanalytical Chemistry. 2006; 384(2): 431-437.
16.    Coskun NY, Aycan S, Sungur S. Differential pulse polarographic determination of pravastatin sodium in tablets. Pharmazie. 1997; 52(6): 485-486.
17.    Dumousseaux C, Muramatsu S, Takasaki W, Takahagi H. Highly sensitive and specific determination of pravastatin sodium in plasma by high-performance liquid chromatography with laser-induced fluorescence detection after immobilized antibody extraction. J. Pharm. Sci. 1994; 83: 1630-1636.
18.    Iacona I, Regazzi MB, Buggia I, Villani P, Fiorito V, Molinaro M, Guarnone E. High-performance liquid chromatographic determination of pravastatin in plasma. Ther. Drug Monit. 1994; 16: 191-195.
19.    Whigan DB, Ivashkiv E, Cohen AI. Determination of pravastatin sodium and its isomeric metabolite in human urine by HPLC with UV detection. J. Pharm. Biomed. Anal. 1989; 7(7): 907-912.
20.    Bauer S, Mwinyi J, Stoeckle A, Gerloff T, Roots I. Quantification of pravastatin in human plasma and urine after solid phase extraction using high performance liquid chromatography with ultraviolet detection. J. Chromatogr. B. 2005; 818: 257-262.
21.    Siekmeier R, Gross W, Marz W. Determination of pravastatin by high-performance liquid chromatography. Int. J. Clin. Pharmacol. Therap. 2000; 38: 419–425.
22.    Otter K, Mignat C. Determination of pravastatin in human plasma by high-performance liquid chromatography with ultraviolet detection. J. Chromatogr. B. 1998; 708(1-2): 235-241.
23.    Zhu ZM, Neirinck L. High performance liquid chromatography coupled with negative ion tandem mass spectrometry for determination of pravastatin in human plasma. J. Chromatogr. B. 2003; 783(1): 133-140.
24.    Jemal M, Qing Y, Whigan DB. The use of high-flow high performance liquid chromatography coupled with positive and negative ion electrospray tandem mass spectrometry for quantitative bioanalysis via direct injection of the plasma/serum samples. Rapid Commun. Mass Spectrom. 1998; 12: 1389-1399.
25.    Mulvana D, Jemal M, Pulver SC. Quantitative determination of pravastatin and its biotransformation products in human serum by turbo ion spray LC/MS/MS. J. Pharm. Biomed. Anal. 2000; 23: 851-866
26.    Kawabata K, Matsushima N, Sasahara K. An automated method for the simultaneous determination of pravastatin and its main metabolite in human plasma by high-performance liquid chromatography-atmospheric-pressure chemical ionization mass spectrometry. Biomed. Chromatogr. 1998; 12: 271-275.
27.    Morris MJ, Gilbert JD, Hsieh JYK, Matuszewski BK, et al. Determination of the HMG-CoA reductase inhibitors simvastatin, lovastatin and pravastatin in plasma by gas chromatography-chemical-ionization mass spectrometry. Biol. Mass Spectrom. 1993; 22: 1-8.
28.    Funke PT, Ivashkiv E, Arnold ME, Cohen AI. Determination of pravastatin sodium and its major metabolites in human serum and plasma by capillary gas chromatography - negative-ion chemical-ionization mass spectrometry. Biomed. Environ. Mass Spectrom. 1989; 18: 904-909.
29.    Cai KH, Tan BY, Feng ZY, Li ZW, Huang M, Zhao XL. The quantitative determination of pravastatin in plasma by a gas chromatography-mass spectrometry method. Sepu. 1996; 14: 121-123.
30.    Kudige N P, Kanakapura B, Madihalli S R. Simple and Selective Spectrophotometric Determination of Ofloxacin in Pharmaceutical Formulations Using Two Sulphonphthalein Acid Dyes. Hindawi Publishing Corporation.2013.
31.    Amina A S, Goudab A El-F, El-Sheikh R b, Zahran F. Spectrophotometric Determination of Gatifloxacin in Pure Form and in Pharmaceutical Formulation. Spectrochimica Acta Part A. 2007; (67): 1306–1312.
32.    Britton H.T.S., Hydrogen Ions, fourth ed., Chapman and Hall, 1952.
33.    Pharmacopeia USP34 NF 29 2011.

Recomonded Articles:

Author(s): Ravindranath S. Misal, Vishawas R. Potphode, Vijay R. Mahajan

DOI: 10.5958/0974-360X.2017.00218.9         Access: Open Access Read More

Author(s): Niharika, Navneet Verma

DOI: 10.5958/0974-360X.2016.00182.7         Access: Open Access Read More

Author(s): A. S. K. Sankar, B. Datchayani, N. Balakumaran, Mohammed Rilwan, R. Subaranjani

DOI: 10.5958/0974-360X.2017.00047.6         Access: Open Access Read More

Author(s): U.S Mahadeva Rao, Khamsah Suryati Mohd, Abdurrazaq Muhammad, Bashir Ado Ahmad, Mohaslinda Mohamad, Rosmawati Mat Ali

DOI: Not Available         Access: Open Access Read More

Author(s): Khan MU, Ghafoor A, Ishaq MT, Hasan B, Salman A, Tengku MA, Zubaidi AL, Nodrin S, Atif AB, Ilyas MN

DOI: 10.5958/0974-360X.2018.00794.1         Access: Open Access Read More

Author(s): Peethala Prathyusha, Raja Sundararajan, Palyam Bhanu, Mathrusri Annapurna Mukthinuthalapati

DOI: 10.5958/0974-360X.2020.00507.7         Access: Closed Access Read More

Author(s): Narendra Chotai, Vishnu Patel, Harsha Patel, Uren Patel, Rajendra Kotadiya

DOI:         Access: Open Access Read More

Author(s): Mayanka Singh, Manoj Charde, Rajesh Shukla, Rita M. Charde

DOI: Not Available         Access: Open Access Read More

Author(s): Archana Kushwaha, Jayanti Jaiswal, Priya Singh, Neha Rathore, Jai Prakash Dhruw, Ishu Sahu, Chhaya Singh, Krinsha Kumar Sahu, Mukta Agrawal, D. K. Tripathi, Ajazuddin, Amit Alexander

DOI: 10.5958/0974-360X.2017.00270.0         Access: Open Access Read More

Author(s): Mukta D. Naykode, Durgacharan A. Bhagwat, Swapnil D. Jadhav, Harinath N. More

DOI: 10.5958/0974-360X.2017.00133.0         Access: Open Access Read More

Author(s): Suha Alnaeb, Youssef Alahmad, Saleh Trefi

DOI: 10.5958/0974-360X.2019.01035.7         Access: Open Access Read More

Author(s): Bahubali N. Patil, Vamshi Krishna Tippavajhala, Girish Pai K

DOI: 10.5958/0974-360X.2019.00140.9         Access: Open Access Read More

Author(s): Vijayalakshmi. S , Disalva. X, Chittaranjan Srivastava, Arun A

DOI: 10.5958/0974-360X.2019.00520.1         Access: Open Access Read More

Author(s): Homendra Kumar Sahu, Kamdev Sen, Raju Patel, Hulash Sahu, Deepika Sahu, Gulshan Sahu, Chandrashekhar Jain, Narayan Prasad Chandra, Mukta Agrawal, D. K. Tripathi, Ajazuddin, Amit Alexander

DOI: 10.5958/0974-360X.2017.00173.1         Access: Open Access Read More

Author(s): R Deveswaran, S Bharath, BV Basavaraj, Sindhu Abraham, Sharon Furtado, V Madhavan

DOI:         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags