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Method Validation For Estimation Of Atenolol and Indapamide in Tablet Formulation
Corresponding Author(s) : Tanya Sharma
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 13 No. 3 (2025): 2025 Volume -13 - Issue 3
Abstract
This study focuses on the method validation for the estimation of Atenolol and Indapamide in tablet formulation using High-Performance Liquid Chromatography (HPLC). The method involves using a mobile phase of methanol:water (55:45) with 0.1% v/v Ammonium Hydroxide, a Phenomenex C18 analytical column, and UV detection at 260nm. The method was validated for parameters such as selectivity, specificity, linearity, precision, limit of detection, and limit of quantification. The results showed that the method is reproducible, accurate, and precise for the estimation of Atenolol and Indapamide in tablet formulation.
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- Lachman L, Liberman H A, Kanig J L, Hanna S A, Lin K. The theory and Practice of industrial Pharmacy. 3rd ed. Vargehese Publishing House Bombay; 1991: 804-55.
- Chatwal G R, Arora M , Pharmaceutical Chemistry- Inorganic. 2nd ed(1). Himalaya Publishing House, Mumbai; 1999: 25-27.
- Mend ham J, et al. Vogel’s Textbook of Quantitative Chemical Analysis. 6th ed. New Delhi: Pearson education (Singapore) Pvt. Ltd. Ind Branch; 2003:630: 3-8.
- Skoog D A, Holler P J, Nieman T A. Principle of Instrumental Analysis. 5th ed. Thomson Brooks/cole Publication; 2004:301:1-4.
- Wilson & Wilson. A series of Comprehensive Analytical Chemistry. Edited by G. Svelha, analytical Visible and UV-Spectroscopy, Vol. XIX, (1986), 1-7, 339-358, 653-656.
- Mellon M G. In Analytical Absorption Spectroscopy, Absorptiometry and Colorimetry. Jhon Wiley and sons, New York; 1952(20).
- El-Sayed Y, Abdel-Aziz, El-Salem Nabej A. Recent Deveopment of Derivative Spectrophotometry and their Analytical Applications; Analytical Sciences; 2005:21: 595-609.
- T C O, Haver. Analytical Chemsitry; 1979: 51(1): 91 A.
- Khopkar S M. Basic Concepts of Analytical Chemistry. Marcel Dekkar, Inc. New York; 1971: 3
- Willard H H, Merritt L L, Dean J A, Settle F A. Instrumental Method Of Analysis. 6 th ed. CBS Publishers; 82-83.
- Connors K A. A textbook of Pharmaceutical Analysis. 3rd ed. Jhon Wiley and Sons; 1982: 173:179: 221-23.
- Sharma Y R. Introduction of Organic Spectroscopy. 4th ed. CBS Publishers and Distributors, New Delhi; 1991: 22.
- Kalsi P S. Spectroscopy of Organic Compounds. 5th ed. New Age International Publishers, New Delhi; 2002.
- Beckett A H and Stenlake J B. Practical Pharmaceutical Chemistry. 4th ed. Vol 2. CBS publishers and Distributors, New Delhi; 2002:275-337.
- Instruction Manual UV-1601, Operation Guide. Shimazhu Corporation. Analytical instrument division, Japan.
- Munson J W. HPLC Theory, Instrumentation and Pharmaceutical Applications; Pharmaceutical Analysis, Modern Methods. 2nd ed.; 1981: 15-39.
- Breaux J, Jones K, Boulas P. Analytical Methods, Development and Validation; Pharmaceutical Technology Analytical Chemistry & Testing.; 2003.
- Effective HPLC method Development; YCL 08/22/01: 1-8. 19. Technical Article on How do I Devlelop an HPLC Method by SGE International Ltd.; 2001.
- Sharma B K. High Performance Liquid Chromatography; Instrumental Method of Chemical Analysis. Goel Publishing House. 15thed.; 1996: 37-61.
- Synder L R, Glajch J J. Non-Ionic Samples: Reversed and Normal-Phase HPLC; Practical HPLC Method Development. John Willey and Sons, Inc; New York. 2nd ed; 1997: 233-291.
- Instruction Manual HPLC 20-AD, Operation Guide, Shimazhu Corporation, Analytical instrument division, Japan.
- Ahuja S, Scypinski S. Handbook of Modern Pharmaceutical Analysis. Academic Press, USA; 2001: 86-172.
- Gad S C. Pharmaceutical Manufacturing Handbook: Regulations and Quality. John Wiley & Sons, Inc.; 2008: 727-42.
- The Indian Pharmacopeia, vol. 1. The Controller of Publication, New Delhi; 1996:74- 75.
- The British Pharmacopeia vol.I, II. The Department of Health, The stationary Office on Behalf of the Medicines and Helathcare products Regulatory Agency (MHRA), London.; 2010: 158-159, 898-900.
- http://en.wikipedia.org/wiki/Atenolol
- Http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?Cid=2249
- Http://www.drugbank.ca/drugs/APRD00172
- Http://www.chemspider.com/Chemical-Structure.2162
- Http://en.wikipedia.org/wiki/Indapamide
- Http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?Cid=3702
- Http://www.drugbank.ca/drugs/APRD01031 34. Http://www.chemspider.com/Chemical-Structure.3574
- Tripathi K D. Essentials of Medical Pharmacology. 5th ed. Jaypee brothers.; 2003: 125-129, 507-508.
- Wilson & Gliswold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry. 11th ed. Lippincott Williams & Wilkins; 2003: 544-545, 607-610.
- Chatwal, G. R., & Arora, M. (1999). Pharmaceutical Chemistry - Inorganic (2nd ed.). Himalaya Publishing House.
References
Lachman L, Liberman H A, Kanig J L, Hanna S A, Lin K. The theory and Practice of industrial Pharmacy. 3rd ed. Vargehese Publishing House Bombay; 1991: 804-55.
Chatwal G R, Arora M , Pharmaceutical Chemistry- Inorganic. 2nd ed(1). Himalaya Publishing House, Mumbai; 1999: 25-27.
Mend ham J, et al. Vogel’s Textbook of Quantitative Chemical Analysis. 6th ed. New Delhi: Pearson education (Singapore) Pvt. Ltd. Ind Branch; 2003:630: 3-8.
Skoog D A, Holler P J, Nieman T A. Principle of Instrumental Analysis. 5th ed. Thomson Brooks/cole Publication; 2004:301:1-4.
Wilson & Wilson. A series of Comprehensive Analytical Chemistry. Edited by G. Svelha, analytical Visible and UV-Spectroscopy, Vol. XIX, (1986), 1-7, 339-358, 653-656.
Mellon M G. In Analytical Absorption Spectroscopy, Absorptiometry and Colorimetry. Jhon Wiley and sons, New York; 1952(20).
El-Sayed Y, Abdel-Aziz, El-Salem Nabej A. Recent Deveopment of Derivative Spectrophotometry and their Analytical Applications; Analytical Sciences; 2005:21: 595-609.
T C O, Haver. Analytical Chemsitry; 1979: 51(1): 91 A.
Khopkar S M. Basic Concepts of Analytical Chemistry. Marcel Dekkar, Inc. New York; 1971: 3
Willard H H, Merritt L L, Dean J A, Settle F A. Instrumental Method Of Analysis. 6 th ed. CBS Publishers; 82-83.
Connors K A. A textbook of Pharmaceutical Analysis. 3rd ed. Jhon Wiley and Sons; 1982: 173:179: 221-23.
Sharma Y R. Introduction of Organic Spectroscopy. 4th ed. CBS Publishers and Distributors, New Delhi; 1991: 22.
Kalsi P S. Spectroscopy of Organic Compounds. 5th ed. New Age International Publishers, New Delhi; 2002.
Beckett A H and Stenlake J B. Practical Pharmaceutical Chemistry. 4th ed. Vol 2. CBS publishers and Distributors, New Delhi; 2002:275-337.
Instruction Manual UV-1601, Operation Guide. Shimazhu Corporation. Analytical instrument division, Japan.
Munson J W. HPLC Theory, Instrumentation and Pharmaceutical Applications; Pharmaceutical Analysis, Modern Methods. 2nd ed.; 1981: 15-39.
Breaux J, Jones K, Boulas P. Analytical Methods, Development and Validation; Pharmaceutical Technology Analytical Chemistry & Testing.; 2003.
Effective HPLC method Development; YCL 08/22/01: 1-8. 19. Technical Article on How do I Devlelop an HPLC Method by SGE International Ltd.; 2001.
Sharma B K. High Performance Liquid Chromatography; Instrumental Method of Chemical Analysis. Goel Publishing House. 15thed.; 1996: 37-61.
Synder L R, Glajch J J. Non-Ionic Samples: Reversed and Normal-Phase HPLC; Practical HPLC Method Development. John Willey and Sons, Inc; New York. 2nd ed; 1997: 233-291.
Instruction Manual HPLC 20-AD, Operation Guide, Shimazhu Corporation, Analytical instrument division, Japan.
Ahuja S, Scypinski S. Handbook of Modern Pharmaceutical Analysis. Academic Press, USA; 2001: 86-172.
Gad S C. Pharmaceutical Manufacturing Handbook: Regulations and Quality. John Wiley & Sons, Inc.; 2008: 727-42.
The Indian Pharmacopeia, vol. 1. The Controller of Publication, New Delhi; 1996:74- 75.
The British Pharmacopeia vol.I, II. The Department of Health, The stationary Office on Behalf of the Medicines and Helathcare products Regulatory Agency (MHRA), London.; 2010: 158-159, 898-900.
http://en.wikipedia.org/wiki/Atenolol
Http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?Cid=2249
Http://www.drugbank.ca/drugs/APRD00172
Http://www.chemspider.com/Chemical-Structure.2162
Http://en.wikipedia.org/wiki/Indapamide
Http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?Cid=3702
Http://www.drugbank.ca/drugs/APRD01031 34. Http://www.chemspider.com/Chemical-Structure.3574
Tripathi K D. Essentials of Medical Pharmacology. 5th ed. Jaypee brothers.; 2003: 125-129, 507-508.
Wilson & Gliswold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry. 11th ed. Lippincott Williams & Wilkins; 2003: 544-545, 607-610.
Chatwal, G. R., & Arora, M. (1999). Pharmaceutical Chemistry - Inorganic (2nd ed.). Himalaya Publishing House.