SIMULTANEOUS DETERMINATION OF FLUPENTIXOL AND NORTRIPTYLINE HCl USING RP-HPLC WITH PDA DETECTOR

SUGANDHA KUMAR P.; KANTIPUDI RAMBABU

doi:10.22159/ijap.2022v14i6.46120

Authors

SUGANDHA KUMAR P. Department of Chemistry, RVR and JC College of Engineering, Guntur 522019, A. P., India
KANTIPUDI RAMBABU Department of Chemistry, RVR and JC College of Engineering, Guntur 522019, A. P., India

DOI:

https://doi.org/10.22159/ijap.2022v14i6.46120

Keywords:

Nortriptyline HCl, Flupentixol, RP-HPLC, Development, Validation

Abstract

Objective: In the current investigation, to separated and validate the cancer healing drugs (Nortriptyline HCl and Flupentixol) through the HPLC (e-2695) instrument containing a PDA detector.

Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Nortriptyline HCl and Flupentixol. The chromatographic strategy utilized Agilent eclipse XDB column of dimensions 250x4.6 mm, 5 micron, using isocratic elution with a mobile phase of Methanol and 0.1% orthophosphoric acid (40:60). A flow rate of 1 ml/min and a detector wavelength of 250 nm utilizing the PDA detector were given in the instrumental settings. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines.

Results: LOD and LOQ concentrations for Flupentixol were 0.015 µg/ml, 0.05 µg/ml and for Nortriptyline HCl were 0.3 µg/ml, 1.0 µg/ml. The calibration charts plotted were linear with a regression coefficient of R²>0.999. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range.

Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of production samples and to verify the quality of drug samples during stability studies.

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References

Lally J, MacCabe JH. Antipsychotic medication in schizophrenia: a review. Br Med Bull. 2015;114(1):169-79. doi: 10.1093/ bmb/ldv017, PMID 25957394.

Budman CL. The role of atypical antipsychotics for the treatment of Tourette’s syndrome: an overview. Drugs. 2014;74(11):1177-93. doi: 10.1007/s40265-014-0254-0, PMID 25034359.

Laursen TM, Nordentoft M, Mortensen PB. Excess early mortality in schizophrenia. Annu Rev Clin Psychol. 2014;10:425-48. doi: 10.1146/annurev-clinpsy-032813-153657, PMID 24313570.

Agarwal P, Sarris CE, Herschman Y, Agarwal N, Mammis A. Schizophrenia and neurosurgery: A dark past with hope of a brighter future. J Clin Neurosci. 2016;34:53-8. doi: 10.1016/j.jocn.2016.08.009. PMID 27634495.

Shen X, Xia J, Adams CE. Flupenthixol versus placebo for schizophrenia. Cochrane Database Syst Rev. 2012;11:CD009777. doi: 10.1002/14651858.CD009777.pub2. PMID 23152280.

Johnson DA. A double-blind comparison of flupenthixol, nortriptyline and diazepam in neurotic depression. Acta Psychiatr Scand. 1979;59(1):1-8. doi: 10.1111/j.1600-0447.1979.tb06940.x. PMID 369298.

Young JP, Hughes WC, Lader MH. A controlled comparison of flupenthixol and amitriptyline in depressed outpatients. Br Med J. 1976;1(6018):1116-8. doi: 10.1136/bmj.1.6018.1116, PMID 773506.

Tam W, Young JP, John G, Lader MH. A controlled comparison of flupenthixol decanoate injections and oral amitriptyline in depressed out-patients. Br J Psychiatry. 1982;140:287-91. doi: 10.1192/bjp.140.3.287, PMID 7093597.

Hawton K, Witt KG, Taylor Salisbury TL, Arensman E. Pharmacological interventions for self-harm in adults (PDF). Cochrane Database Syst Rev. 2015;7:CD011777:CD011777. doi: 10.1002/14651858.

Kaur J, Ghosh S, Sahani AK, Sinha JK. Mental imagery training for treatment of central neuropathic pain: a narrative review. Acta Neurol Belg. 2019;119(2):175-86. doi: 10.1007/s13760-019-01139-x, PMID 30989503.

Al-Quliti KW. Update on neuropathic pain treatment for trigeminal neuralgia. The pharmacological and surgical options. Neurosciences (Riyadh). 2015;20(2):107-14. doi: 10.17712/nsj.2015.2.20140501, PMID 25864062.

Foreman DM. Attention deficit hyperactivity disorder: legal and ethical aspects. Arch Dis Child. 2006;91(2):192-4. doi: 10.1136/adc.2004.064576, PMID 16428370.

Faraone SV, Larsson H. Genetics of attention deficit hyperactivity disorder. Mol Psychiatry. 2019;24(4):562-75. doi: 10.1038/s41380-018-0070-0, PMID 29892054.

Kalkhoran S, Benowitz NL, Rigotti NA. Prevention and treatment of tobacco use: JACC Health Promotion series. J Am Coll Cardiol. 2018;72(9):1030-45. doi: 10.1016/j.jacc.2018. 06.036. PMID 30139432.

Robinson OJ, Pike AC, Cornwell B, Grillon C. The translational neural circuitry of anxiety. J Neurol Neurosurg Psychiatry. 2019;90(12):1353-60. doi: 10.1136/jnnp-2019-321400, PMID 31256001.

Healy D, Le Noury J, Mangin D. Enduring sexual dysfunction after treatment with antidepressants, 5α-reductase inhibitors and isotretinoin: 300 cases. Int J Risk Saf Med. 2018;29(3-4):125-34. doi: 10.3233/JRS-180744, PMID 29733030.

Rochester MP, Kane AM, Linnebur SA, Fixen DR. Evaluating the risk of QTc prolongation associated with antidepressant use in older adults: a review of the evidence. Ther Adv Drug Saf. 2018;9(6):297-308. doi: 10.1177/2042098618772979, PMID 29854391.

Stein DJ. What is a mental disorder? A perspective from cognitive-affective science. Can J Psychiatry. 2013;58(12):656-62. doi: 10.1177/070674371305801202, PMID 24331284.

Sharma AN, Hoffman RJ. Toxin-related seizures. Emerg Med Clin North Am. 2011;29(1):125-39. doi: 10.1016/j.emc.2010.08.011, PMID 21109109.

Kowalik U, Plante MK. Urinary retention in surgical patients. Surg Clin North Am. 2016;96(3):453-67. doi: 10.1016/j.suc.2016.02.004. PMID 27261788.

Mi XS, Yuan TF, So KF. The current research status of normal tension glaucoma. Clin Interv Aging. 2014;9:1563-71. doi: 10.2147/CIA.S67263. PMID 25258525.

Berrios GE. Of mania: introduction. Hist Psychiatry. 2004;15(57 Pt 1):105-24. doi: 10.1177/0957154X04041829, PMID 15104084.

Gillman PK. Tricyclic antidepressant pharmacology and therapeutic drug interactions updated. Br J Pharmacol. 2007;151(6):737-48. doi: 10.1038/sj.bjp.0707253. PMID 17471183.

Glazener C, Evans J, Glazener PR, Cathryn MA, editors. Tricyclic and related drugs for nocturnal enuresis in children. Cochrane Database Syst Rev. 2016:pub2:CD002117:CD002117. doi: 10.1002/14651858.

Srinivasan S, Sadegh L, Elle IC. Serotonin regulates C. elegans fat and feeding through independent molecular mechanisms. Cell Metab. 2008;7(6):533-44. doi: 10.1016/j.cmet.2008.04.012, PMID 18522834.

Orsulak PJ. Therapeutic monitoring of antidepressant drugs: guidelines updated. Ther Drug Monit. 1989;11(5):497-507. doi: 10.1097/00007691-198909000-00002, PMID 2683251.

Subrahmanyam Talari AV, prathyusha Ks, New A. Validated RP-HPLC method for cisplatin and topotecan in API and vaccine form and its stress studies. Int J Res Pharm Sci. 2021;12:808-14.

Syed Rafi, Kantipudi Rambabu. Stability indicating validated HPLC method for the determination of aceclofenac and misoprostol in bulk and pharmaceutical formulation. IJRPS 2020;11(4):7848-53. doi: 10.26452/ijrps.v11i4.4669.

Bhavani P, Prasada Rao K, Mohan S. Novel validated reversed-phase high-performance liquid chromatography method for determination of glucosamine, diacerein, and methyl sulfonyl methane in micro-sample rat plasma and its application to pharmacokinetic and dissolution studies. Asian J Pharm Clin Res. 2020;13:50-63. doi: 10.22159/ajpcr.2020.v13i12.36547.

Shivani CP, Maheshwari DG. Development and validation of UV spectrometric and HPLC method for estimation of escitalopram oxalate and flupentixol dihydrochloride in the combined dosage form. AJPTI. 2016;4:59-70.

Naresh Kumar DS, Patel D. Stability indicating chromatographic method development and validation for the simultaneous estimation of escitalopram oxalate and flupentixol in its pharmaceutical dosage form by HPLC. WJPR. 2017;6:549-66.

Supriya T, Naresh D, Vijaya Kumar G, Haneer MA. Stability indicating RP-HPLC method development and validation for simultaneous estimation of escitalopram and flupentixol pure and marketed formulation. Asian J Pharm Res. 2018;8:4-10.

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.

Naykode MD, Bhagwat DA, Jadhav SD, More HN. Analytical and bioanalytical method for quantification of pure azilsartan, not its salts by RP-HPLC. Res J Pharm Technol. 2017;10(3):708-14. doi: 10.5958/0974-360X.2017.00133.0.

Singh M, Charde M, Shukla R, Rita MC. Determination of calcipotriene in calcipotriene cream 0.05% w/w by RP-HPLC method development and validation. Res J Pharm Technol. 2011;4:1219-23.

Eluru A, 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.

Senthil Rajan D, Muruganathan G, Shivkumar K, Ganesh T. Development and validation of HPLC method for simultaneous quantification of vasicine, glycyrrhizin and piperine in poly herbal cough syrup. Int J Curr Pharm Res. 2020;12:15-9.

Malak Y, Al-Bathish AA, gazy MK, El-Jamal. RP-HPLC and chemometric methods for the determination of two antidiabetic mixtures; metformin hydrochloride-canagliflozin and metformin hydrochloride-gliclazide in their pharmaceutical formulation. Int J Pharm Pharm Sci. 2020;12:83-94.

Gadhvi MP, Bhandari A, Suhagia BN, Desai UH. Development and validation of RP-HPLC method for simultaneous estimation of atazanavir and ritonavir in their combined tablet dosage form. Res J Pharm Technol. 2013;6:200-3.

Swati K, Abhishek P, Sushank S, Bothiraja C, Atmaram P. High-performance liquid chromatography for the simultaneous estimation of cefoperazone and sulbactam in rat plasma and its importance in therapeutic drug monitoring. Int J Pharm Pharm Sci. 2020;12:92-7.

Gomathy S, Narenderan ST, Meyyanathan SN, Gowramma B. Development and validation of hplc method for the simultaneous estimation of apigenin and luteolin in commercial formulation. Crit Rev. 2020;7:4785-90.

Vijayakumari M, Reddy Ch B. 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.

Raziq A. Syed Umer Jan. Relative comparison of stability and degradation of methylcobalamin 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 the 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.

Athavia BA, Dedania ZR, Dedania RR, Swamy SMV, Prajapati CB. Stability indicating HPLC method for determination of vilazodone hydrochloride. Int J Curr Pharm Sci 2017;9(4). doi: 10.22159/ijcpr.2017v9i4.20975.

Unade TT, Krishnamanjari Pawar A. A new stability indicating UPLC method for the determination of two anti-diabetic drugs in combination: applications to bulk and tablet formulation. Int J Appl Pharm. 2022;14:192-9.

Manoranjani M. A study of method development, validation and forced degradation for simultaneous quantification of cisplatin and fluorouracil in bulk and pharmaceutical dosage form by RP-HPLC. J Pharm Sci and Res. 2021;13: 155-61.

Prasada Rao PTSRK. A study of method development and validation of pemetrexed and cisplatin using RP-HPLC. J Pharm Sci and Res. 2021;13:143-8.

Satya Dev S. TNVSS. A new selective method development and validation of cabozantinib and Nivolumab using HPLC. J Pharm Sci and Res. 2021;13:188-92.

Manoranjani M. Assay method development and validation of cilnidipine and ramipril, characterization of its degradants by using LC-MS/MS. Int J Appl Pharm. 2022;14:276-85. doi: 10.22159/ijap.2022v14i2.43570.

Prasada Rao PTSRK. HPLC method development and validation of lercanidipine HCl and aatenolol, characterization of its degradants by using LC-MS/MS. Int J Appl Pharm. 2022;14:125-34.

Satya Dev S. TNVSS, Chintalapudi Ramakrishna. A new related substances method development and validation of two anti-cancer drugs by using an effective liquid chromatographic method. Int J Appl Pharm. 2022;14:116-24.

David Raju M. Simultaneous method development and validation of choline salicylate and tannic acid using RP-HPLC in bulk and pharmaceutical dosage form. Int J Appl Pharm.. 2022;14:227-35.

David Raju M. Development and validation of HPLC method for the determination of lasmiditan drug in bulk and tablet dosage form. J Pharm Sci and Res. 2021;13:170-3.