Author(s):
Shashank Soni, Veerma Ram, Divya Verma, Anurag Verma
Email(s):
ssoni@lko.amity.edu
DOI:
10.5958/0974-360X.2021.00166.9 
Address:
Shashank Soni1*, Veerma Ram2, Divya Verma3, Anurag Verma4
1Department of Pharmaceutics, Amity Institute of Pharmacy, Amity University, Uttar Pradesh, Lucknow Campus, Lucknow, India.
2School of Pharmaceutical Sciences and Technology, Sardar Bhagwan Singh University, Dehradun, India.
3Department of Chemistry, University of Lucknow, Lucknow, India.
4School of Pharmaceutical Sciences, IFTM University, Moradabad, India.
*Corresponding Author
Published In:
Volume - 14,
Issue - 2,
Year - 2021
ABSTRACT:
Metoprolol Succinate (MS) is a ß 1- blocker and a drug of choice for a patient suffering from cardiovascular diseases. Referable to the highly probable over dosage, a rapid and easy to execute a method for the quantitative determination of MS in biologic matrices would be utilitarian in its therapeutic monitoring as well as in intoxication cases. The report presents two validated methods for detection of MS by UV-VIS and HPLC. The parameters targeted for the validation were: specificity, range, detection and quantification limits, accuracy, and precision and were determined according to International Conference on Harmonization ICH Q2 (R1) guidelines. HPLC was conducted on the Water Spherisorb® analytical column (5µm, 4.6 x 250mm). The mobile phase consisted of a buffer (ACN: orthophosphoric acid: water; pH 3.0) and the flow rate was maintained at 2.0ml/min. MS was monitored using the Water Breeze 2 system equipped with photodiode array detector (? = 224nm) and also by a UV-VIS spectrophotometer (? = 224nm) by Shimadzu UV 1800. Linearity was observed in concentration range of 10–50µg/ml by HPLC and 2-10µg/ml by UV spectroscopy method. The correlation coefficient was 0.9992 and 0.9998. All in all, the system suitability parameters were set up inside the range as per ICH. The performed method is rapid, cost-effective and can be used as a quality-control method for routine quantitative analysis of MS in pure and pharmaceutical dosage forms.
Cite this article:
Shashank Soni, Veerma Ram, Divya Verma, Anurag Verma. Analytical Method Development and Validation of Metoprolol Succinate by High Performance Liquid Chromatography and Ultraviolet Spectroscopy Technique. Research J. Pharm. and Tech. 2021; 14(2):931-937. doi: 10.5958/0974-360X.2021.00166.9
Cite(Electronic):
Shashank Soni, Veerma Ram, Divya Verma, Anurag Verma. Analytical Method Development and Validation of Metoprolol Succinate by High Performance Liquid Chromatography and Ultraviolet Spectroscopy Technique. Research J. Pharm. and Tech. 2021; 14(2):931-937. doi: 10.5958/0974-360X.2021.00166.9 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2021-14-2-62
REFERENCES:
1. Bhadra S, Das SC, Roy S, Arefeen S, Rouf AS. Development and validation of RP-HPLC method for quantitative estimation of vinpocetine in pure and pharmaceutical dosage forms. Chromatography Research International. 2011; 2011: 1-7 doi: 10.4061/2011/801656
2. Blomqvist I, Westergren G, Sandberg A, Jonsson UE, Lundborg P. Pharmacokinetics and pharmacodynamics of controlled-release metoprolol: a comparison with atenolol. European Journal of Clinical Pharmacology. 1988; 33(1): 519-524.
3. Brunton LL, Lazo JS, Parker KI. 2005. Goodman and Gilman's. The Pharmacological Basis of Therapeutics. United States; McGraw Hill.
4. El-Gindy A, Emara S, Mesbah MK, Hadad GM. Spectrophotometric and liquid chromatographic determination of fenofibrate and vinpocetine and their hydrolysis products. Farmaco. 2005; 60(5):425-38.
5. Green JM. A practical guide to analytical method validation. Analytical chemistry. 1996; 68(9): 305A-9A.
6. ICH Q2 (R1), 2005. Validation on Analytical Procedures: Text and Methodology. International Conference on Harmonisation, Geneva, Switzerland.
7. ICH. Q2B, 1996. Validation of Analytical Procedures-Methodology. Consensus- Guidelines, ICH Harmonized Tripartite Guidelines, Geneva, Switzerland.
8. Jenke DR. Chromatographic Method Validation: A Review of Current Practices and Procedures. II. Guidelines for Primary Validation Parameters. Journal of liquid chromatography and related technologies. 1996; 19(5): 737-57.
9. Jenke DR. Chromatographic method validation: A review of current practices and procedures. III. Ruggedness, re-validation and system suitability. Journal of Liquid Chromatography and Related Technologies. 1996; 19(12): 1873-91.
10. Ptaszynski P., Kaczmarek K., Ruta J., Klingenheben T., Wranicz JK. Metoprolol succinate vs. ivabradine in the treatment of inappropriate sinus tachycardia in patients unresponsive to previous pharmacological therapy. Europace. 2012; 15(1): 116-21.
11. Rosing H, Man WY, Doyle E, Bult A, Beijnen JH. Bioanalytical liquid chromatographic method validation. A review of current practices and procedures. Journal of Liquid Chromatography and Related Technologies. 2000; 23 (3): 329-354.
12. Sahoo M, Syal P, Ingale S, Ingale K, Sindhe S, Sali M, Choudhari VP, Kuchekar BS. Development and Validation of a RP-HPLC-PDA method for Simultaneous Determination of Lornoxicam and Thiocolchicoside in Pharmaceutical dosage form and its Application for Dissolution study. Int J Res Pharm Sci. 2011; 2(1):1-7.
13. Sarkar AK, Ghosh D, Das A, Selvan PS, Gowda KV, Mandal U, Bose A, Agarwal S, Bhaumik U, Pal TK. Simultaneous determination of metoprolol succinate and amlodipine besylate in human plasma by liquid chromatography-tandem mass spectrometry method and its application in bioequivalence study. Journal of Chromatography B. 2008; 873(1): 77-85.
14. Sharma P, Contractor P, Guttikar S, Patel DP, Shrivastav PS. Development of a sensitive and rapid method for quantitation of (S)-(−)-and (R)-(+)-metoprolol in human plasma by chiral LC-ESI–MS/MS. Journal of Pharmaceutical Analysis. 2014; 4(1): 63-79.
15. Shrivastava A, Gupta V. Methods for the determination of limit of detection and limit of quantitation of the analytical methods. Chronicles of Young Scientists. 2011; 2(1): 21-.21.
16. United States Pharmacopeia. 2009. 32nd edition, Validation of Compendial Methods. Rockville, USA.
17. Vatsova M, Tzvetanov S, Drenska A, Goranscheva J, Tyutyulkova N. Improved gas chromatographic–mass spectrometric method for the quantitative determination of vinpocetine in human plasma. Journal of Chromatography B: Biomedical Sciences and Applications. 1997; 702(1): 221-26.
18. Wikstrand J, Andersson B, Kendall MJ, Stanbrook H, Klibaner M. Pharmacokinetic considerations of formulation: extended-release metoprolol succinate in the treatment of heart failure. Journal of Cardiovascular Pharmacology. 2003; 41(2):151-157.