DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF ENALAPRIL MALEATE IN PRESENT OF THEIR IMPURITIES: APPLICATION TO TABLET ANALYSIS
Objective: A simple, rapid, economical, and highly sensitive stability-indicating HPLC method was developed and fully validated for determination of enalapril maleate in presence of its related substances namely enalaprilat dihydrate and diketopiperazine.
Methods: Chromatographic separation was achieved on Grace PlatinumÑ€ C8 EPS column (4.6 mm i.d. X 250 mm, 5 Î¼m) at room temperature. The mobile phase consisted of acetonitrile: 20 mmol phosphate buffer adjusted to pH 2.2 (25:75 v/v) isocratically pumped at a flow rate 2 ml/min and UV-detection was monitored at 215 nm.
Results: The proposed method was validated according to ICH guidelines with total run time less than 9 min. The correlation coefficient (r2) was noted as 0.99981 which states that the method was good linear to the concentration versus peak area responses. The developed method found to be high sensitivity with LOD and LOQ of 0.021 and 0.062 %; respectively. The developed, validated method was successfully applied for the determination of enalapril maleate in presence of their impurities in tablet dosage form.
Conclusion: A rapid, economical, simple and sensitive HPLC method was developed and validated for the determination of enalapril maleate in tablet dosage form in presence of their impurities. The developed method can help research studies, quality control and routine analysis with lesser resources available. Therefore, the proposed validated method is fast and reliable and can be used for routine quantitative analysis as well as quality control of enalapril maleate in pharmaceutical formulation.
2. Rahman N, Manirul HS. Optimized and validated spectro-photometric methods for the determination of enalapril maleate in commercial dosage forms. Anal Chem Insights 2008;3:31â€“43.
3. Manoranjani M, Karuna KK. UV-visible spectroscopic estimation and validation of enalapril maleate in bulk and pharmaceutical dosage forms. Int J Res Pharm Biomed Sci 2011;2:1651â€“6.
4. Sowjanya G, Gangadhar P, Rao RP, Subrahmanyam P, Suresh P. Simultaneous UV spectrphotometric estimation of enalapril maleate and hydrochlorothiazide in tablets. J Chem Pharm Res 2012;4:3483â€“8.
5. Stanisz B. Evaluation of stability of enalapril maleate in solid phase. J Pharm Biomed Anal 2003;31:375.
6. Santos EL, Souza KP, Da Silva ED, Batista EC, Martins PJF, Almeida VD, et al. Long term treatment with ACE inhibitor enalapril decreases body weight gain and increases life span in rats. Biochem Pharmacol 2009;78:951-8.
7. Al-Omari MM, Abdelah MK, Badwan AA, Jaber AMY, Mohan. Effect of the drug-matrix on the stability of enalapril maleate in tablet. J Pharm Biomed Anal 2001;25:831-902.
8. Gu ML, Strickley RG. A profound solvent effect on the diketopiperazine formation of the new dipeptide angiotensin converting enzyme inhibitor, Moexipril. Int J Pharm 1990;60:99â€“107.
9. Stanisz B. Kinetics of degradation of enalapril maleate in dosage forms. Acta Poloniae Pharm 2004;61:415-8.
10. Lima D, Dos Santos L, Lima E. Stability and in vitro release profile of enalapril maleate from different commercially available tablets: possible therapeutic implications. J Pharm Biomed Anal 2008;47:934.
11. Roskar R, Simoncic Z, Gartner A, Kmetec V. Stability of new potential ACE inhibitor in the aqueous solutions of different pH. J Pharm Biomed Anal 2009;49:295.
12. Melander WR, Jacobson J, Horvath C. Effect of molecular structure and conformational change of proline-containing dipeptides in reversed phase chromatography. J Chromato-graphy 1982;234:269-76.
13. Sciences Manindra Mohan, S Zafar Haider, Ankur K Anand, Amit K Srivastva. Validation of stability indicating HPLC method for the determination of enalapril maleate in tablet formulations. Int J Pharm Pharm 2011;3:180-3.
14. Mennickent SC, Rivas C, Vega MA, De Diego MD. A stability indicating HPTLC method for quantification of enalapril maleate in tablets. J Chilean Chem Soc 2013;58:1737â€“40.
15. Bhardwaj SP, Singh S. Study of forced degradation behavior of enalapril maleate by LC and LCâ€“MS and development of a validated stability-indicating assay method. J Pharm Biomed Anal 2008;46:113â€“20.
16. Ghosh C, Jain I, Shinde CP, Chakraborty BS. Rapid and sensitive liquid chromatography/tandem mass spectrometry method for simultaneous determination of enalapril and its major metabolite enalaprilat, in human plasma: application to a bioequivalence study. Drug Testing Anal 2012;4:94â€“103.
17. Danafar H, Hamidi M. Liquid chromatographyâ€“tandem mass spectrometry (LC-MS) method for the assignment of enalapril and enalaprilat in human plasma; Pharm Biomed Res 2015;1:47â€“58.
18. European Pharmacopoeia. Enalapril maleate monograph. 8th ed. European Department for the Quality of Medicines, Strasbourg, France; 2016. [Last accessed on 01 Jun 2017]
19. ICH Q2 (R1), Validation of analytical procedures, Text and methodology. International Conference on Harmonization, Geneva; 2005. p. 1-17.
20. Liliya Logoyda, Dmytro Korobko, Iryna Ivanusa, Kovalenko Serhii. Development of the methodology of the chromatographic determination of nifedipine in medicines. Asian J Pharm Clin Res 2017;10:149-52.
21. Raul SK, Aravelli AB, Jhansi D. RP-HPLC method development and validation for the simultaneous estimation of atorvastatin and ezetimibe in pharmaceutical dosage form. Asian J Pharm Clin Res 2015;8:178-81.