Determination of Lansoprazole and Simvastatin via area under curve and ion pair methods
Main Article Content
Abstract
A two simple, sensitive, and economic methods were developed for the determination of lansoprazole and simvastatin in their pure and pharmaceutical dosages forms . first method based on measurement of area under curve (AUC) for zero order spectrum and the second method based on formation of ion pair complex between each of both drugs and Bromo phenol blue dye. Beer's law obeyed in concentrations ranges of (4-70 μg.ml-1) and (4-50 μg.ml-1) in the first method and (1-70 μg.ml-1) and (1-60 μg.ml-1) in the second method for lansoprazole (LNZ) and simvastatin (SMV) respectively . Average recovery percentage were (99.43%) and (99.36%) in the first method , and (99.71%) and (100.18%) in the second method for LNZ and SMV respectively. The RSD% values were (0.0044-0.0172%) and (0.1041-0.4129%) for LNZ in first and second methods, and (0.0097-0.0311%) and (0.1358-0.5165%) for SMV in the two methods mentioned above. Limit of detection of LNZ in the first method were (0.185×10-3 μg.ml-1) and (0.268×10-3 μg.ml-1) in the second method . While limit of quantification were (0.227×10-3 μg.ml-1) and (0.204×10-3 μg.ml-1) in the first method and (0.894×10-3 μg.ml-1) and (0.68×10-3 μg.ml-1) in the second method for LNZ and SMV respectively. The two methods were successfully applied for the determination of both drugs in pure and pharmaceutical dosages forms .
Article Details

This work is licensed under a Creative Commons Attribution 4.0 International License.
Tikrit Journal of Pure Science is licensed under the Creative Commons Attribution 4.0 International License, which allows users to copy, create extracts, abstracts, and new works from the article, alter and revise the article, and make commercial use of the article (including reuse and/or resale of the article by commercial entities), provided the user gives appropriate credit (with a link to the formal publication through the relevant DOI), provides a link to the license, indicates if changes were made, and the licensor is not represented as endorsing the use made of the work. The authors hold the copyright for their published work on the Tikrit J. Pure Sci. website, while Tikrit J. Pure Sci. is responsible for appreciate citation of their work, which is released under CC-BY-4.0, enabling the unrestricted use, distribution, and reproduction of an article in any medium, provided that the original work is properly cited.
References
1. Indian Pharmacopoeia. Indian Pharmacopoeia
Commission. Ghaziabad, 2014, Vol: 2, p: 2067-2070.
2. Ruth Beulah, V. and Shantha Kumari, A.
"Spectrophotometric Determination of Poorly Water
Soluble Drug Lansoprazole Using Hydrotropic
Solubilization Technique". IAJPR, 2013, Vol: 3,
Issue: 8 .
3. British pharmacopeia. British Pharmacopoeia
Commission, 2010.
4. Satoh H. Discovery of lansoprazole and its unique
pharmacological properties independent from antisecretory
activity, Curr. Pharm. Design, 2013, Vol:
19, p: 67–75 .
5. Subrata kumar bala , Sudhansu Ranjan Swain,
Satyabrata Bhanja and Muvvala Sudhakar.
Formulation and Evaluation of Delayed Release
Orally Disintegrating Tablets of Lansoprazole.
IAJPR. 2013, Vol 3, Issue 8 .
6. Mayuri R. Ghadge, Vrushali S. Tambe and Pallavi
G. Darade. Analysis of Proton Pump Inhibitors in
Bulk and In Different Dosage Forms -A Review.
IJPRR, 2014, Vol: 3(1), p: 45-57.
7. Sherif Abdel‐Naby Abdel‐Gawad and Zeinab
Abdelaziz Elsherif: Development and validation of
spectrophotometric methods for simultaneous
determination of sitagliptin and simvastatin in binary
mixture. IJPIR , 2013 , Vol: 3, Issue: 1, p: 53-60 .
8. Sanjay Sawant and Minal Ghante. A validated
Stability Indicating RP-HPLC Method for
Simvastatin, Identification and Characterization of
Forced Degradation Products of Simvastatin Using
LC-ESI-MS/MS. Advances in Analytical Chemistry,
2015, Vol: 5, Issue: 1 , p: 8-16 .
9. Shilpa Emani, Gayathri V. Gunjiganur and
Dhoom Singh Mehta. Determination of the
antibacterial activity of simvastatin against
periodontal pathogens, Porphyromonas gingivalis and
Aggregatibacter actinomycetemcomitans: An in vitro
study. Contemporary Clinical Dentistry, 2014 , Vol:
5, Issue: 3.
10. Sharma Sheetal, Manocha Nimita, Bhandari
Priya, Harsoliya Sohail and Jain Prabhat.
Development of UV-Spectrophotometry and RPHPLC
Method and its Validation for Simultaneous
Estimation of Sitagliptin Phosphate and Simvastatin
in Marketed Formulation. IJPBA, 2012, Vol: 3, Issue:
3, p: 673-678 .
11. Kothari Ankur and Sheetal. Simultaneous UVSpectrophotometric
Method for Estimation of
Sitagliptin Phosphate and Simvastatin in Tablet
Dosage Form. JPR, 2012, Vol:5, Issue:1, p: 444-446 .
12. Mitka M. "Cholesterol drug controversy
continues". JAMA, 2008, Vol: 299 Issue :19, p: 2266.
13. Sanne Tofte Rasmussen, et al . Simvastatin and
Oxidative Stress in Humans: A Randomized, Double
Blinded, Placebo-Controlled Clinical Trial. Redox
Biology, 2016, Vol: 9, P: 32–38 .
14. Okram Zenita Devi, Kanakapura Basavaiah and
Kanakapura Basavaiah Vinay. Quantitative
determination of lansoprozole in capsules and spiked
human urine by spectrophotometry through ion-pair
complex formation reaction. JSCS , 2013, Vol:17, p:
387–396 .
15. Singh Sunil et al. Validated RP-UPLC Method
Development for Estimation of Lansoprazole in
Tablet Dosage Form. IJPSDR , 2013, Vol: 5, Issue: 3,
p: 105-107.
16. Foram Jaysukhlal Chodvadiya, Krupa
Chaitanyakumar Thula and Dilip Girishbhai
Maheshwari. Simultaneous Estimation of Aspirin and
Lansoprazole by RP–HPLC Method. IJRSR, 2015,
Vol: 6, Issue: 4, P:3385-3390.
17. Suéllen Cristina Rennó Silva, Gustavo Rodrigues
de Rezende and Vanessa Bergamin Boralli. Quick
and Simple LC-MS/MS Method For The
Determination of Simvastatin in Human Plasma:
Application to Pharmacokinetics and Bioequivalence
Studies. BJPS, 2014, Vol: 50 , Issue : 3.
18. Harshal Garse and Vilasrao Kadam. Development
and Validation of Bioanalytical Method for Analysis
of Simvastatin. IAJPR, 2014, Vol: 4, Issue: 4 .
19. Madhu Latha, Ammani D, Jitendra Kumar K,
Nagaraju P. and Mallikharjuna Rao P. "Validation
Stability Indicating HPLC Method for Simultaneous
Determination of Simvastatin and Ezetimibe in Bulk
Drug and Pharmaceutical Formulation". IJRPC, 2014,
Vol: 4, Issue :2 , p: 406-414 .
20. Naga Raju K, Sudheer Babu I, Jyothi R and
Prathyusha S. Spectrophotometric Methods for
Estimation of Simvastatin in Bulk Drug and its
Dosage Form. IJPCBS, 2012, Vol: 2, Issue:1, p:124-
129.