DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RELATED SUBSTANCES OF ATENOLOL AND NITRENDIPINE BY RP-HPLC
Keywords:Atenolol, Nitrendipine, Related impurities, HPLC, Validation
Objective: A validated stability-indicating RP-HPLC method for Atenolol and Nitrendipine 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 Atenolol, Nitrendipine and its related impurities was achieved on the column of Agilent eclipse C18 (150x4.6mm, 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 218 nm utilizing the PDA detector were given in the instrumental settings. The linearity was studied between the concentration range of 6.25-37.5 µg/ml of Atenolol, 0.75-4.5 µg/ml each of Atenolol imp-A, imp-B and 5-30 µg/ml of Nitrendipine, 0.5-3 µg/ml each of Nitrendipine imp-1, imp-2 were injected with a run time of 40 min. Validation of the proposed method was carried out according to an International Conference on Harmonization (ICH) guidelines.
Results: LOD and LOQ for the Atenolol 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, Atenolol, Nitrendipine and their related impurities). Since, there is no HPLC method reported in the literature for the estimation of Atenolol, Nitrendipine and their related impurities, there is a need to develop quantitative methods under different conditions to achieve improvement in specificity, selecivity etc.
Larochelle P, Tobe SW, Lacourcière Y. β-Blockers in hypertension: studies and meta-analyses over the years. Can J Cardiol 2014; 30 (5 Suppl): S16–22.
Zipursky JS, Macdonald EM, Luo J, Gomes T, Mamdani MM, Paterson JM, Juurlink DN. Lipophilic β-Blockers and Suicide in the Elderly. J Clin Psychopharmacol 2017; 37: 381–4.
Poulter NR, Prabhakaran D, Caulfield M. Hypertension. Lancet 2015; 386: 801–12.
Wertli MM, Ruchti KB, Steurer J, Held U. Diagnostic indicators of non-cardiovascular chest pain: a systematic review and meta-analysis. BMC Med 2013; 11: 239.
Tomiyama H, Yamashina A. Beta-Blockers in the Management of Hypertension and/or Chronic Kidney Disease. Int J Hypertens 2014; 2014: 919256.
DiNicolantonio JJ, Fares H, Niazi AK, Chatterjee S, D'Ascenzo F, Cerrato E, et al. β-Blockers in hypertension, diabetes, heart failure and acute myocardial infarction: a review of the literature. Open Heart 2015; 2: e000230.
McMurray JJ, Pfeffer MA. Heart failure. Lancet 2005; 365: 1877–89.
Pandey A, Garg S, Khunger M, Darden D, Ayers C, Kumbhani DJ, et al. Dose-Response Relationship Between Physical Activity and Risk of Heart Failure: A Meta-Analysis. Circulation 2015; 132: 1786–94.
Chu EC, Chin WL, Bhaumik A. Cervicogenic dizziness. Oxford Medical Case Reports 2019; 2019: 476–8.
Shiber JR, Santana J. Dyspnea. Med Clin North Am 2006; 90: 453–79.
Torres M, Moayedi S. Evaluation of the acutely dyspneic elderly patient. Clin Geriatr Med 2007; 23: 307–25, vi.
Hu LA, Chen W, Martin NP, Whalen EJ, Premont RT, Lefkowitz RJ. GIPC interacts with the beta1-adrenergic receptor and regulates beta1-adrenergic receptor-mediated ERK activation. J Biol Chem 2003; 278: 26295–301.
Devereaux D, Tewelde SZ. Hyperthyroidism and thyrotoxicosis. Emerg Med Clin North Am 2014; 32: 277–92.
Tobin KJ. Stable angina pectoris: what does the current clinical evidence tell us?. J Am Osteopath Assoc 2010; 110: 364–70.
Titterington JS, Hung OY, Wenger NK. Microvascular angina: an update on diagnosis and treatment. Future Cardiol 2015; 11: 229–42.
El-Sherif N, Turitto G, Boutjdir M. Acquired Long QT Syndrome and Electrophysiology of Torsade de Pointes. Arrhythm Electrophysiol Rev 2019; 8: 122–30.
Mustafic H, Jabre P, Caussin C, Murad MH, Escolano S, Tafflet M, et al. Main air pollutants and myocardial infarction: a systematic review and meta-analysis. JAMA 2012; 307: 713–21.
Roach RE, Helmerhorst FM, Lijfering WM, Stijnen T, Algra A, Dekkers OM. Combined oral contraceptives: the risk of myocardial infarction and ischemic stroke. Cochrane Database Syst Rev 2015; CD011054.
Al-Zaiti SS, Magdic KS. Paroxysmal Supraventricular Tachycardia: Pathophysiology, Diagnosis, and Management. Crit Care Nurs Clin North Am 2016; 28: 309–16.
Baldzizhar A, Manuylova E, Marchenko R, Kryvalap Y, Carey MG. Ventricular Tachycardias: Characteristics and Management. Crit Care Nurs Clin North Am 2016; 28: 317–29.
Farrell JB, Deshmukh A, Baghaie AA. Low testosterone and the association with type 2 diabetes. Diabetes Educ 2008; 34: 799–806.
Lindholm LH, Ibsen H, Borch-Johnsen K, Olsen MH, Wachtell K, Dahlöf B, et al. Risk of new-onset diabetes in the Losartan Intervention For Endpoint reduction in hypertension study. J Hypertens 2002; 20: 1879–86.
Elliott WJ, Meyer PM. Incident diabetes in clinical trials of antihypertensive drugs: a network meta-analysis. Lancet 2007; 369: 201–7.
Lindholm LH, Carlberg B, Samuelsson O. Should β blockers remain first choice in the treatment of primary hypertension? A meta-analysis. Lancet 2005; 366: 1545–53.
Khan N, McAlister FA. Re-examining the efficacy of beta-blockers for the treatment of hypertension: a meta-analysis. CMAJ 2006; 174: 1737–42.
Messerli FH, Grossman E, Goldbourt U. Are beta-blockers efficacious as first-line therapy for hypertension in the elderly? A systematic review. JAMA 1998; 279: 1903–7.
Trouve R, Nahas G. Nitrendipine: an antidote to cardiac and lethal toxicity of cocaine. Proc Soc Exp Biol Med 1986; 183: 392–7.
Asif A, Siddiqui A, Polsker GL. Fixed-Dose Combination Enalapril/Nitrendipine: A Review of its use in mild-to-moderate hypertension. Drugs 2004; 64: 1135–48.
Shivaraj Gowda, Prakash B Desai, Vinayak V Hull, Avinash AK Math, Sonal N Venekar, Shruthi S Kulkarni. A review on laboratory liver function tests. The Pan African Medical Journal 2009; 3: 17.
Geyer PE, Kulak NA, Pichler G, Holdt LM, Teupser D, Mann M. Plasma Proteome Profiling to Assess Human Health and Disease. Cell Syst 2016; 2: 185–95.
Obach R Scott, Esbenshade Timothy A. Pharmacologically Active Drug Metabolites: Impact on Drug Discovery and Pharmacotherapy. Pharmacol Rev 2013; 65: 578–640.
Indik Julia H. When Palpitations Worsen. Am J Med 2010; 123: 517–9.
Cijo M Xavier, Kanakapura Basavaiah. RP-UPLC Development and validation of Metformin Hydrochloride in pure drug and pharmaceutical formulations. World journal of pharmacy and pharmaceutical sciences 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 App 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 App Pharm 2021; 13: 165-72.
V L N 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 App Pharm 2021; 13: 153-9.
Murali Krishnam Raju P, Venkata Narayana B, Shyamala P, Srinivasu K, H S N Raju D. A validated RP-HPLC method for impurity profiling of Sodium nitroprusside in injection dosage form. Int J App 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 Iodine 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 App Pharm 2021; 13: 207-13.
Abdul Raziq, Syed Umer Jan et al., Relative comparison of stability and degradation of methylcobalamine tablets of different brands at different storage settings. Int J App Pharm 2021; 13: 171-5.
Rajakumari R, Sreenivasa Rao S et.al., 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 et.al., Stability indicating HPLC method for determination of Vilazodone hydrochloride. Int J Curr Pharm Res 2017; 9: 123-9.
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