DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RELATED SUBSTANCES OF TRANDOLAPRIL BY RP-HPLC AND ITS DEGRADATION

CHALLA SUDHEER REDDY; B. TIRUMALESWARA RAO

doi:10.22159/ijap.2021v13i5.42113

Authors

CHALLA SUDHEER REDDY Department of Chemistry, Vikas PG College, Vissannapeta, Andhra Pradesh, India 521215
B. TIRUMALESWARA RAO Department of Chemistry, Vikas PG College, Vissannapeta, Andhra Pradesh, India 521215

DOI:

https://doi.org/10.22159/ijap.2021v13i5.42113

Keywords:

Trandolapril, Related impurities, HPLC, Development, Validation

Abstract

Objective: A validated stability-indicating RP-HPLC method for Trandolapril was developed by separating its related impurities.

Methods: By using Waters HPLC e-2695 quaternary pump with a PDA detector of 2998 instrument the chromatographic separation of Trandolapril and its related impurities was achieved on the column of Agilent eclipse C₁₈ (150x4.6 mm, 3.5 µ) using gradient elution with a buffer containing 0.1percent formic acid and acetonitrile as a mobile phase with a flow rate of 1 ml/min at ambient temperature. A detector wavelength of 213 nm utilizing the PDA detector were given in the instrumental settings. The linearity was studied between the concentration range of 4-60 µg/ml of Trandolapril and 0.5-7.5 µg/ml of imp-E, imp-A, imp-B and 0.7-10.5 µg/ml of imp-D were injected with a run time of 17 min. Validation of the proposed method was carried out according to an International Conference on Harmonization (ICH) guidelines.

Results: LOD and LOQ for the Trandolapril and its impurities were established with respect to test concentration. The plotted calibration curves were linear with a regression coefficient of R²>0.999, indicates that the linearity was with in the limit. As a part of method validation the parameters like specificity, linearity, accuracy, ruggedness, robustness were determined and the results were found to be within the allowable limit.

Conclusion: The method developed was found to be applicable to routine analysis and to be used for the measurement of active pharmaceutical ingredients (i. e, Trandolapril and its related impurities). Since, there is no HPLC method reported in the literature for the estimation of Trandolapril and its related impurities, there is a need to develop quantitative methods under different conditions to achieve improvement in specificity, selecivity etc.

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References

Van Vark LC, Bertrand M, Akkerhuis KM, Brugts JJ, Fox K. Angiotensin-converting enzyme inhibitors reduce mortality in hypertension: a meta-analysis of randomized clinical trials of renin–angiotensin–aldosterone system inhibitors involving 158,998 patients. Eur Heart J 2012;33:2088–97.

Augenstein, Vedra A, Heniford B Todd, Sing, Ronald F. ıntestinal angioedema ınduced by angiotensin-converting enzyme ınhibitors: an underrecognized cause of abdominal pain. J Am Osteopath Assoc 2013;113:221–3.

Musini VM, Gueyffier F, Puil L, Salzwedel DM, Wright JM. Pharmacotherapy for hypertension in adults aged 18 to 59 y. Cochrane Database Syst Rev 2017;8:CD008276.

Arguedas, Jose Agustin, Leiva, Viriam, Wright, James M. Blood pressure targets in adults with hypertension. Cochrane Database Syst Rev 2020;12:CD004349.

Freeman Roy, Abuzinadah, Ahmad R, Gibbons, Christopher, Jones, et al. Orthostatic hypotension: JACC state-of-the-art review. J Am Coll Cardiol 2018;72:1294–309.

Shen J, Barbera J, Shapiro CM. Distinguishing sleepiness and fatigue: focus on definition and measurement. Sleep Med Rev 2006;10:63–76.

Rejnmark L, Vestergaard P, Pedersen AR, Heickendorff L, Andreasen F, Mosekilde L. Dose-effect relations of loop-and thiazide-diuretics on calcium homeostasis: a randomized, double-blinded latin-square multiple cross-over study in postmenopausal osteopenic women. Eur J Clin Invest 2003;33:41–50.

Magaldi, Antonio J. New insights into the paradoxical effect of thiazides in diabetes insipidus therapy. Nephrol Dial Transplant 2000;15:1903–5.

Smellie, W Stuart A. Spurious hyperkalaemia Br Med J 2007;334:693–5.

Kovesdy CP. Updates in hyperkalemia: outcomes and therapeutic strategies. Rev Endocr Metab Disord 2016;18:41–7.

Bellinger DC. Teratogen update: lead and pregnancy. Birth Defects Res (Part A) Clin Mol Teratol 2005;73:409–20.

Chute, Michael, Aujla, Preetinder, Jana. the non-fibrillar side of fibrosis: contribution of the basement membrane, proteoglycans, and glycoproteins to myocardial fibrosis. Cardiovasc Dev Dis 2019;6:35.

Woodford HJ, George J. Diagnosis and management of urinary infections in older people. Clin Med 2011;11:80–3.

Simerville, Jeff A. Urinalysis: a comprehensive review. Am Fam Physician 2005;71:1153–62.

Kumar R, Singh VP, Baker KM. The intracellular renin–angiotensin system in the heart. Curr Hypertens Rep 2009;11:104–10.

Brown MJ. Success and failure of vaccines against renin–angiotensin system components. Nat Rev Cardiol 2009;6:639–47.

Obach R Scott, Esbenshade, Timothy A. Pharmacologically active drug metabolites: ımpact on drug discovery and pharmacotherapy. Pharmacol Rev 2013;65:578–640.

Yang PJ, Pham J, Choo J, Hu DL. Duration of urination does not change with body size. Proc Natl Acad Sci USA 2014;111:11932–7.

Rose C, Parker A, Jefferson B, Cartmell E. the characterization of feces and urine: a review of the literature to ınform advanced treatment technology. Crit Rev Environ Sci Technol 2015;45:1827–79.

Cijo M Xavier, Kanakapura Basavaiah. RP-UPLC development and validation of metformin hydrochloride in pure drug and pharmaceutical formulations. World J Pharm Pharm Sci 2015;4:1649-68.

Shalini K, Ilango K. Development, evaluation and RP-HPLC method for simultaneous estimation of quercetin, ellagic acid and kaempferol in a poly herbal formulation. Int J Appl Pharm 2021;13:183-92.

Sri Girija K, Bikshal Babu K, Venkateswara Rao A. A new high performance liquid chromatography method for the separation and simultaneous quantification of eptifibatide and its impurities in pharmaceutical injection formulation. Int J Appl Pharm 2021;13:165-72.

VLN Balaji Gupta T, Venkateswara Rao B, Kishore Babu B. RP-HPLC (stability indicating) based assay method for the simultaneous estimation of doravirine, tenofovir disoproxil fumarate and lamivudine. Int J Appl Pharm 2021;13:153-9.

Murali Krishnam Raju P, Venkata Narayana B, Shyamala P, Srinivasu K, HSN Raju D. A validated RP-HPLC method for impurity profiling of Sodium nitroprusside in injection dosage form. Int J Appl Pharm 2021;13:160-9.

Sanathoiba Singha L, Srinivasa Rao T. Development and validation of an RP-HPLC method for the determination of ulipristal acetate in pharmaceutical dosage form. Asian J Pharm Clin Res 2021;14:83-9.

Asha Eluru, Surendra Babu K. A study of method development, validation and forced degradation for simultaneous quantification of povidone ıodine and ornidazole in bulk and pharmaceutical dosage form by using RP-HPLC. IJPSR 2021;12:1217-22.

Malathi S, Devakumar D. Development and validation of rp-hplc method for the estimation of escitalopram oxalate and flupentixol dihydrochloride in combined dosage form and plasma. Int J Pharm Pharm Sci 2021;13:61-6.

International Conference on Harmonization (ICH). Harmonized tripartite guideline validation of analytical procedures: Text and methodology Q2 (R1). Geneva: IFPMA, Switzerland; 2005.

Ravichandran V, Shalini S, Sundaram KM, Rajak H. Validation of analytical methods-strategies and importance. Int J Pharm Pharm Sci 2010;2:18-22.

Raviteja G, Rambabu K. A study of development and validation of a method for simultaneous estimation of cidofovir and famciclovir using RP-HPLC. Int J Res Pharm Sci 2020;11:7878-84.

Vijayakumari M, Balasekhar Reddy Ch. Stability indicating validated hplc method for the determination of zanubrutinib in bulk and pharmaceutical dosage form. Asian J Pharm Clin Res 2020;13:159-62.

Mohinish Sahai, N Devanna. Validated stability indicating HPLC approach for quantifying tricholine citrate and cyproheptadine simultaneously in syrup forms. Int J Appl Pharm 2021;13:207-13.

Abdul Raziq, Syed Umer Jan. Relative comparison of stability and degradation of methylcobalamine tablets of different brands at different storage settings. Int J Appl Pharm 2021;13:171-5.

Rajakumari R, Sreenivasa Rao S. Stress degradation studies and development of a validated RP-HPLC method for determination of tiagabine in presence of its degradation products. Int J Pharm Pharm Sci 2016;8:230-6.

Charu Pandya P, Sadhana Rajput J. Development and validation of stability indicating method RP-HPLC method of acotiamide. Int J Pharm Pharm Sci 2018;10:1-8.

Birva Athavia A, Zarna Dedania R. Stability indicating HPLC method for determination of vilazodone hydrochloride. Int J Curr Pharm Res 2017;9:123-9.