VALIDATED STABILITY-INDICATING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE ESTIMATION OF TORSEMIDE
Objective: This assessment depicts the strength of exhibiting reverse-phase high performance liquid chromatography (RP-HPLC) method for the estimation of torsemide in pharmaceutical estimation structures.
Methods: In the present work, total protein-HPLC technique has been produced for the estimation of torsemide active pharmaceutical ingredient (API). Constrained degradation HPLC strategy was created with versatile mobile phase of methanol:water in the proportion of 90:10 v/v. The stream pace of 1 ml/min was utilized on Inertsil ODS 3V segment (250 mm×4.6 mm, 5 μm molecule size).
Results: The retention time of torsemide was seen at 8.267 min, method was validated for all validation parameters as per the International Council for Harmonization guidelines. The linearity range was 10–60 μg/ml, correlation coefficient was 0.9993, and percentage relative standard deviation in the precision studies was <2%, with percentage recovery 100.56–101.03 (within acceptable range of 98–102%). The assay result was found to be 100.88% (i.e., within 95–105%), passes the specifications for robustness parameters. Limit of detection of torsemide was found to be 0.0162 μg/ml and limit of quantitation of torsemide was found to be 0.0534 μg/ml.
Conclusion: The medication was exceptionally delicate to antacid pursued by at risk to corrosive, photolytic, warm, and oxidative conditions. The created and approved method showing HPLC technique is observed to be direct, exact, precise, explicit, and powerful. Henceforth, the technique can be utilized routinely for the estimation of torsemide API.
2. Guul SJ, Jounela AJ. The efficacy and tolerability of enalapril with a formulation with a very low dose of hydrochlorothiazide in hypertensive patients resistant to enalapril monotherapy. Am J Hypertens 1995;8:727.
3. Tamilselvan T, Veerapandiyan AK, Karthik N. Study on drug utilization pattern of chronic renal failure patients in a tertiary care hospital. Int J Pharm Pharm Sci 2014;6:482-4.
4. Eby M, Chandrika C, Preethy MK, Srinivasa R. A prospective observational study on prescribingt and adversed reactions in stroke patients. Int J Pharm Pharm Sci 2017;9:25-30.
5. Dirks JH, Sutton RA. Diuretics: Physiology, Pharmacology, and Clinical Use. Philadelphia, PA: WB Saunders; 1986.
6. Gennaro AR. The Science and Practice of Pharmacy. 21st ed. Pennsylvania: Lippincott Williams and Wilkins; 2005. p. 537-44.
7. Stenlake JB, Beckett AH. Practical Pharmaceutical Chemistry. 4th ed., Vol. 2. New Delhi: CBS Publishers and Distributors; 2002. p. 85-170.
8. British Pharmacopoeia. The Stationary Office under the License from the Controller of her Majesty’s Stationary Office for the Health Department; 2007. p. 2058-9.
9. Khan IJ, Loya P, Saraf MN. A simplified HPLC method for quantification of torsemide from human plasma and its application to a bioequivalence study Indian J Pharm Sci 2008;70:519-22.
10. Adelaida B, Gamboa A, Julio NA, Cecilia CM, Villagra AR, Lopez M, et al. Quantitative analysis of torsemide in human plasma by high performance liquid chromatography with ultraviolet detection. Rev Mex Patol Clin 2011;58:95-200.
11. Sharma S, Sharma MC, Kohli DV, Chaturvedi SC. Isocratic reverse phase HPLC estimation method of torsemide and spironolactone in pharmaceutical combined dosage form. Optoelectron Adv Mater Rapid Commun 2010;4:234-7.
12. Sharma S, Sharma MC, Kohli DV, Sharma AD. Development and validation of TLC densitometry method for simultaneous quantification of montelukast sodium and levocetirizine dihydrochloride pharmaceutical solid dosage form. Pharm Lett 2010;2:489-94.
13. Tijare LK, Rangari NT, Mahajan UN. A review on bioanalytical method development and validation. Asian J Pharm Clin Res 2016;9:6-10.
14. Code Q2 A-Text on Validation of Analytical Procedure Step-3 Consensus Guideline, ICH Harmonised Tripartite Guideline; 1994.
15. Code Q2B Validation of Analytical Procedure Methodology Step-4 Consensus Guideline, ICH Harmonised Tripartite Guideline; 1994.
16. Besenfelder E. The determination of torasemide and metabolites in plasma by high performance liquid chromatography. J Pharm Biomed Anal 1987;5:259.
17. Engelhardt S, Meineke I, Brockmoller J. Improved solid-phase extraction and HPLC measurement of torsemide and its important metabolites. J Chromatogr B Analyt Technol Biomed Life Sci 2006;831:31-5.
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.