A NEW RP-UPLC METHOD FOR THE SEPARATION AND SIMULTANEOUS QUANTIFICATION OF DORZOLAMIDE HCl AND TIMOLOL MALEATE

ASHA ELURU; K. SURENDRA BABU

doi:10.22159/ijap.2024v16i3.49491

Authors

ASHA ELURU Department of Chemistry, Acharya Nagarjuna University, Guntur-522510, Andhra Pradesh, India
K. SURENDRA BABU Department of Chemistry, SVRM College, Nagaram-522268, Andhra Pradesh, India

DOI:

https://doi.org/10.22159/ijap.2024v16i3.49491

Keywords:

Dorzolamide HCl, Timolol maleate, Development, Validation, RP-UPLC

Abstract

Objective: This investigation demonstrates a stability-indicating and reliable “reverse-phase ultra-performance liquid chromatography” method to simultaneously quantify timolol maleate and dorzolamide HCl in the pharmaceutical dosage form.

Methods: Successful separation was accomplished using Phenyl column (100 mm x 2.1 mm, 1.7μm) with isocratic type of elution using mobile phase containing Acetonitrile+Ammonium Formate buffer (30:70), respectively with 0.2 ml/min flow rate. The wavelength sensor was attuned at 266 nm to quantify timolol maleate and dorzolamide HCl.

Results: Dorzolamide HCl and timolol maleate peaks were eluted with fine resolution at retention times 0.7 min and 1.5 min, respectively. In the 55.75-334.5 μg/ml and 6.25-37.5 μg/ml concentration ranges for dorzolamide HCl and timolol maleate, the calibration graphs were linear, with regression coefficients of 0.99997 and 0.99991, respectively. The suggested ultra-performance liquid chromatography approach has been shown as sensitive, precise, robust, accurate, specific and stability, indicating through the resolution of dorzolamide HCl and timolol maleate from its degradation-based compounds.

Conclusion: The established ultra-performance liquid chromatography technique was effectively extended to the evaluation of dorzolamide HCl and timolol Maleate in the pharmaceutical dosage form and the test results appeared satisfactory.

Downloads

Download data is not yet available.

References

Davis BM, Crawley L, Pahlitzsch M, Javaid F, Cordeiro MF. Glaucoma: the retina and beyond. Acta Neuropathol. 2016;132(6):807-26. doi: 10.1007/s00401-016-1609-2, PMID 27544758.

Stein JD, Khawaja AP, Weizer JS. Glaucoma in adults-screening, diagnosis, and management: a review. JAMA. 2021;325(2):164-74. doi: 10.1001/jama.2020.21899, PMID 33433580.

Cristina CM, Gerli RL, Carla G. Prevalence of retinopathy in patients with anemia or thrombocytopenia. Eur J Haematol. 2001;67:238-44. doi: 10.1034/j.1600-0609.2001.00539.x.

Lerch M, Mainetti C, Terziroli Beretta Piccoli B, Harr T. Current perspectives on Stevens-Johnson syndrome and toxic epidermal necrolysis. Clin Rev Allergy Immunol. 2018;54(1):147-76. doi: 10.1007/s12016-017-8654-z, PMID 29188475.

Bachelez H. Pustular psoriasis and related pustular skin diseases. Br J Dermatol. 2018;178(3):614-8. doi: 10.1111/bjd.16232, PMID 29333670.

Victora CG, Bahl R, Barros AJ, França GV, Horton S, Krasevec J. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7, PMID 26869575.

Brodribb W. ABM clinical protocol #9: use of galactogogues in initiating or augmenting maternal milk production, second revision 2018. Breastfeed Med. 2nd Revision. 2018;13(5):307-14. doi: 10.1089/bfm.2018.29092.wjb, PMID 29902083.

Swenson ER. Carbonic anhydrase inhibitors and high altitude illnesses. Subcell Biochem. 2014;75:361-86. doi: 10.1007/978-94-007-7359-2_18, PMID 24146388.

Aptel F, Weinreb RN, Chiquet C, Mansouri K. 24-h monitoring devices and nyctohemeral rhythms of intraocular pressure. Prog Retin Eye Res. 2016;55:108-48. doi: 10.1016/j.preteyeres.2016.07.002, PMID 27477112.

Cacho I, Sanchez Naves J, Batres L, Pintor J, Carracedo G. Comparison of intraocular pressure before and after laser in situ keratomileusis refractive surgery measured with Perkins tonometry, noncontact tonometry, and transpalpebral tonometry. J Ophthalmol. 2015;2015:683895. doi: 10.1155/2015/683895, PMID 26167293.

Josefine CF, von Spreckelsen A, Miriam K, Augusto AB, Gianni V. Cochrane eyes and vision group, editors. Rho kinase inhibitor for primary open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022;2022:CD013817. doi: 10.1002/14651858.

Gazzard G, Konstantakopoulou E, Garway Heath D, Garg A, Vickerstaff V, Hunter R. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial. Lancet. 2019;393(10180):1505-16. doi: 10.1016/S0140-6736(18)32213-X, PMID 30862377.

Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2, PMID 36809645.

Coviltir V, Burcel M, Cherecheanu AP, Ionescu C, Dascalescu D, Potop V. Update on myopia risk factors and microenvironmental changes. J Ophthalmol. 2019;2019:4960852. doi: 10.1155/ 2019/4960852, PMID 31781378.

Volotinen M, Turpeinen M, Tolonen A, Uusitalo J, Maenpaa J, Pelkonen O. Timolol metabolism in human liver microsomes is mediated principally by CYP2D6. Drug Metab Dispos. 2007;35(7):1135-41. doi: 10.1124/dmd.106.012906, PMID 17431033.

Canto JG, Shlipak MG, Rogers WJ, Malmgren JA, Frederick PD, Lambrew CT. Prevalence, clinical characteristics, and mortality among patients with myocardial infarction presenting without chest pain. JAMA. 2000;283(24):3223-9. doi: 10.1001/jama.283.24.3223, PMID 10866870.

Merison K, Jacobs H. Diagnosis and treatment of childhood migraine. Curr Treat Options Neurol. 2016;18(11):48. doi: 10.1007/s11940-016-0431-4, PMID 27704257.

Millstine D, Chen CY, Bauer B. Complementary and integrative medicine in the management of headache. BMJ. 2017;357:j1805. doi: 10.1136/bmj.j1805, PMID 28512119.

Mitchell S, Malanda B, Damasceno A, Eckel RH, Gaita D, Kotseva K. A roadmap on the prevention of cardiovascular disease among people living with diabetes. Glob Heart. 2019;14(3):215-40. doi: 10.1016/j.gheart.2019.07.009. PMID 31451236.

Tinajero MG, Malik VS. An update on the epidemiology of type 2 diabetes: a global perspective. Endocrinol Metab Clin North Am. 2021;50(3):337-55. doi: 10.1016/j.ecl.2021.05.013, PMID 34399949.

Myc LA, Shim YM, Laubach VE, Dimastromatteo J. Role of medical and molecular imaging in COPD. Clin Transl Med. 2019;8(1):12. doi: 10.1186/s40169-019-0231-z, PMID 30989390.

Postma DS, Rabe KF. The asthma–COPD overlap syndrome. N Engl J Med. 2015;373(13):1241-9. doi: 10.1056/NEJMra1411863, PMID 26398072.

Batra AS, Balaji S. Fetal arrhythmias: diagnosis and management. Indian Pacing Electrophysiol J. 2019;19(3):104-9. doi: 10.1016/j.ipej.2019.02.007, PMID 30817991.

Kuck KH. Arrhythmias and sudden cardiac death in the COVID-19 pandemic. Herz. 2020;45(4):325-6. doi: 10.1007/s00059-020-04924-0, PMID 32333026.

Belch J, Carlizza A, Carpentier PH, Constans J, Khan F, Wautrecht JC. ESVM guidelines-the diagnosis and management of Raynaud’s phenomenon. Vasa. 2017;46(6):413-23. doi: 10.1024/0301-1526/a000661, PMID 28895508.

Wigley FM, Flavahan NA. Raynaud’s phenomenon. N Engl J Med. 2016;375(6):556-65. doi: 10.1056/NEJMra1507638, PMID 27509103.

Sena DF, Lindsley K. Neuroprotection for treatment of glaucoma in adults. Cochrane Database Syst Rev. 2017(1). doi: 10.1002/14651858.CD006539.pub4.

Kumar AA, Thejomoorthy K, Sreenivasa Prasanna P. Analytical method development and validation for estimation of dorzolamide hydrochloride and timolol maleate in ophthalmic solution by RP-HPLC. World J Pharm Pharm Sci. 2020;9:1274-82.

Nagori BP, Maru A, Muysuni P, Gupta S. Method development and its validation for simultaneous estimation of timolol maleate and dorzolamide hydrochloride in as API and in ophthalmic solution dosage form by RP-HPLC. J Chem Pharm Res. 2011;3:866-74.

Kanchan RU, Shikha MN Roy, Rane RB. Simultaneous RP-HPLC determination of dorzolamide hydrochloride and timolol maleate in pharmaceutical preparations. ACAIJ. 200(7):638-41.

Sher N, Shafi N, Naseem H, Khan MA. A novel RP-HPLC method for simultaneous estimation of dorzolamide and timolol maleate in ophthalmic products. PJC. 2020;10(1-4):1-6. doi: 10.15228/2020.v10.i01-4.p01.

International conference on the harmonization. ICH harmonized tripartite guideline. Validation of analytical procedures: text and methodology Q2(R1); 2005.

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.

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.

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):123-9. doi: 10.22159/ijcpr.2017v9i4.20975.

Shribhumika L, Ramgopal M. Dhanwad, Method development and validation for simultaneous estimation of lamivudine and raltegravir in pure drug form by RP-HPLC. Res J Pharm Technol. 2024;17:1071-5.

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.

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

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

Manoranjani M. Stability indicating assay method development and validation of Netarsudil and latanoprost by RP-HPLC and its degradation. JETIR. 2019;6:825-32.

Prasada Rao PTSRK. Development and validation of adapalene and dapsone in bulk and pharmaceutical dosage form by RP-HPLC and its degradation. JETIR. 2019;6:754-9.

Dev S, T NVSS. Stability indicating assay method development and validation of aclidinium bromide and formoterol fumarate by RP-HPLC. JETIR. 2019;6:625-9.

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 Res. 2021;13:155-61.

Kirubakaran N, Umashankar MS, Bhuvaneshwari S. Analytical methods of estimation of oxetacaine and its quality determinations in different pharmaceutical formulations by reverse phase high-performance liquid chromatography. Res J Pharm Technol. 2023;16:5748-3.

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

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