Author(s): A. Krishnamanjari Pawar, Chandana Mannepalli

Email(s): akmpawar@andhrauniversity.edu.in , chandana.mannepalli@gmail.com

DOI: 10.52711/0974-360X.2024.00314   

Address: A. Krishnamanjari Pawar1*, Chandana Mannepalli2
1Associate Professor, A. U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, India.
2Research Scholar, A. U. College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, India.
*Corresponding Author

Published In:   Volume - 17,      Issue - 5,     Year - 2024


ABSTRACT:
The present work is intended to establish a simple, precise and sensitive stability indicating HPLC method for the separation and simultaneous quantification of timolol, dorzolamide and latanoprost in pharmaceutical formulations. The separation of analytes was achieved on Spherisorb ods2 C18 (250mm × 4.6mm; 5µ)as stationary phase, methanol, acetonitrile and phosphate buffer (pH 5.2) in 55:45:05 (v/v) as mobile phase at 1.0 mL/min and UV detection at 239nm. In this condition, well resolved, retained peaks were identified at 3.45 min fortimolol, 2.66min for dorzolamideand 5.43min for latanoprost. The method reports 0.313µg/mL, 1.25µg/mL and 0.003µg/mL for timolol, dorzolamide and latanoprost respectivelyas LOD that proves that the method have enough sensitivity levels for the detectionanalytes in samples. The method passes all the validation parameters as per the guidelines proved that the method was valid. The method can shows very less % degradation in various stress studies such as acidic, base, peroxide, thermal and UV light conditions and can effectively separate various stress degradation compounds and confirms the stability indicating nature of the method. The method applicability was assessed by analysing the drug content in ophthalmic drops and reports the % assay of be 98.48, 99.37 and 98.32% for timolol, dorzolamide and latanoprost respectively. Based on the results, it can be concluded that the method can adequately suitable for the separation and quantification of timolol, dorzolamide and latanoprost and hence can be applicable for the routine analysis of timolol, dorzolamide and latanoprostin single or any combined ophthalmic formulations.


Cite this article:
A. Krishnamanjari Pawar, Chandana Mannepalli. Development and Validation of Stability Indicting HPLC Method for the Separation and Simultaneous Analysis of Timolol, Dorzolamide and Latanoprost Inophthalmic formulations. Research Journal of Pharmacy and Technology. 2024; 17(5):1983-0. doi: 10.52711/0974-360X.2024.00314

Cite(Electronic):
A. Krishnamanjari Pawar, Chandana Mannepalli. Development and Validation of Stability Indicting HPLC Method for the Separation and Simultaneous Analysis of Timolol, Dorzolamide and Latanoprost Inophthalmic formulations. Research Journal of Pharmacy and Technology. 2024; 17(5):1983-0. doi: 10.52711/0974-360X.2024.00314   Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2024-17-5-10


REFERENCES:
1.    Volotinen Marjo. TurpeinenMiia. Tolonen Ari. Uusitalo Jouko. Maenpaa Jukka. Pelkonen Olavi. Timolol Metabolism in Human Liver Microsomes is Mediated Principally by CYP2D6. Drug Metabolism and Disposition. 2007; 35(7): 1135. doi: 10.1124/dmd.106.012906.
2.    Atkin T,Comai S,Gobbi G. Drugs for Insomnia beyond Benzodiazepines: Pharmacology, Clinical Applications, and Discovery. Pharmacological Reviews. 2018; 70(2): 197. doi: 10.1124/pr.117.014381.
3.    Amano S,Nakai Y,Ko A, Inoue K,Wakakura M. A case of keratoconus progression associated with the use of topical latanoprost. Japanese Journal of Ophthalmology. 2008; 52(4); 334. doi: 10.1007/s10384-008-0554-6.
4.    Hasegawa T, Hara K,Kenmochi T,Hata S. In vitro metabolism of dorzolamide, a novel potent carbonic anhydrase inhibitor, in rat liver microsomes. Drug Metabolism & Disposition. 1994; 22(6): 5.
5.    Martens-Lobenhoffer J,Banditt P. Clinical pharmacokinetics of dorzolamide. Clinical Pharmacokinetics. 2002; 41(3): 197. doi: 10.2165/00003088-200241030-00004.
6.    Martens-Lobenhoffer J,Banditt P. Clinical pharmacokinetics of dorzolamide. Clinical Pharmacokinetics. 2002; 41(3): 197. doi: 10.2165/00003088-200241030-00004.
7.    Alm A. Latanoprost in the treatment of glaucoma. Clinical Ophthalmology. 2014; 26(8): 1967. doi:10.2147/OPTH.S59162.
8.    Amano S,Nakai Y,Ko A, Inoue K,Wakakura M. A case of keratoconus progression associated with the use of topical latanoprost. Japanese Journal of Ophthalmology. 2008; 52(4); 334. doi:10.1007/s10384-008-0554-6.
9.    Erk N. Rapid and sensitive HPLC method for the simultaneous determination of dorzolamide hydrochloride and timolol maleate in eye drops with diodearray and UV detection. Pharmazie. 2003; 58(7): 491.  
10.    Gajanan Darwhekar, Priya Jain, Dinesh Kumar Jain,GauravAgrawal. Development and Optimization of Dorzolamide Hydrochloride and Timolol Maleate in Situ Gel for Glaucoma Treatment. Asian Journal of Pharmaceutical Analysis. 2011; 1(4): 93.
11.    Nitish Sharma, Surendra Singh Rao, Malleswara Reddy A. A Novel and Rapid Validated Stability-Indicating UPLC Method of Related Substances for Dorzolamide Hydrochloride and Timolol Maleate in Ophthalmic Dosage Form, Journal of Chromatographic Science. 2012; 1: doi:10.1093/chromsci/bms025.
12.    Adel EhabIbrahima, Hanaa Salehb, Magda Elhenaweeb. Assessment and validation of green stability indicating RP-HPLC method for simultaneous determination of timolol and latanoprost in pharmaceutical dosage forms using eco-friendly chiral mobile phase. Microchemical Journal. 2019; 148: 21. doi:10.1016/j.microc.2019.04.059.
13.    Mohamed Walash, Rania El-Shaheny. Fast separation and quantification of three antiglaucoma drugs by high-performance liquid chromatography UV detection. Journal of Food and Drug Analysis. 2016; 15(1): doi:10.1016/j.jfda.2015.11.006
14.    Rele RV, Mhatre VV,Parab JM,Warkar CB. Simultaneous RP HPLC determination of Latanoprost and Timolol Maleate in combined pharmaceutical dosage form. Journal of Chemical and Pharmaceutical Research. 2011; 3(1): 138.
15.    Bikshal Babu Kasimala, Venkateswara Rao Anna, Useni Reddy Mallu. Stability-indicating reversed-phase HPLC method for the separation and estimation of related impurities of cilnidipine in pharmaceutical formulations. Indian Drugs. 2018; 55(12): 41. doi:10.53879/id.55.12.11185.
16.    Rajesh Varma Bhupatiraju, Srinivasa Kumar B, Pavani Peddi, Venkata Swamy Tangeti. An effective HPLC method for evaluation of process related impurities of Letermovir and LC-MS/MS characterization of forced degradation compounds. J. Chem. Metrol. 2023; 2(2): 181-198 doi:10.25135/jcm.98.2311.2975
17.    Gajanan Darwhekar, Priya Jain, Dinesh Kumar Jain, Gaurav Agrawal. Development and Optimization of Dorzolamide Hydrochloride and Timolol Maleate in Situ Gel for Glaucoma Treatment. Asian Journal of Pharmaceutical Analysis. 2011; 1(4): 93.
18.    Murali Krishnam Raju P., Shyamala, Venkata Narayana B., Dantuluri HSNR., Bhupatiraju RV. A fast, validated UPLC method coupled with PDA-QDa detectors for impurity profiling in betamethasone acetate and betamethasone phosphate injectable suspension and isolation, identification, characterization of two thermal impurities. Ann. Pharm. Fr. 2022; 80(6): 837-852 doi:10.1016/j.pharma.2022.03.003
19.    ICH Expert Working Group. ICH Harmonised Tripartite Guideline–Validation of Analytical Procedures Text and Methodology: Q2 (R1). InGeneva: International Conference on Harmonisation of Technical Requirements for Registrataion of Pharmaceuticals for Human Use. 2005;
20.    Useni Reddy Mallu,VenkateswaraRao Anna, Bikshal Babu Kasimala. Rapid Stability Indicating HPLC Method for the Analysis of Leflunomide and Its Related Impurities in Bulk Drug and Formulations. Turkish Journal of Pharmaceutical Sciences. 2019;  16(4): 457. doi: 10.4274/tjps.galenos.2018.34635.
21.    Thangabalan B, Avinash Koya, Chaitanya G, Sunitha N, Manohar Babu S. Stability Indicating RP–HPLC Method for the Estimation of Acamprosate in Pure and Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2013; 3(4): 141
22.    Jakaria Md, Hazrat Ali Md, Areeful Haque Md, Mohammed Abu Sayeed, Shoayeb Ahmed. In vitro Comparative Forced Degradation Study of Different Brands and Active form of Montelukast sodium using UV Spectrophotometer. Asian Journal ofPharmaceutical Analysis. 2015; 5(1): 26 doi: 10.5958/2231-5675.2015.00005.8
23.    Rucha AP, Meghna PP, Hasumati AR, Nehal S. Forced Degradation Studies of OlmesartanMedoxomil and Characterization of Its Major Degradation Products by LC-MS/MS, NMR, IR and TLC. Asian Journal of Pharmaceutical Analysis. 2015; 5(3): 119 doi: 10.5958/2231-5675.2015.00019.8
24.    Patel VD, Raj Hasumati. Ranolazine: A Review on Analytical Method and Its Determination in Synthetic Mixture. Asian Journal ofPharmaceutical Analysis. 2015; 5(4): 214 doi:10.5958/2231-5675.2015.00034.4
25.    Chandana OSS,  Ravichandra Babu R. Stability Indicating HPLC Method Development and Validation for Thalidomide and its Impurity Determination. Asian Journal of Pharmaceutical Analysis. 2016; 6(2): 115 doi:10.5958/2231-5675.2016.00017.X
26.    Tentu Nageswara Rao, Imad Hussain, Prashanthi Y, Patrudu TB. Forced Degradation Study for Tolterodine by HPLC with PDA Detection. Asian Journal of Pharmaceutical Analysis. 2019; 9(2):77 doi:10.5958/2231-5675.2019.00015.2
27.    Parag AP, Vinod AB, Yogesh SA, Bhaskar OA. Development and Validation of Stability Indicating UV Spectrophotometric Method for Estimation of Teneligliptine in Bulk and Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2019; 9(3):128 doi: 10.5958/2231-5675.2019.00024.3
28.    Surse SN, Patil SD, Deshmukh KR, Kshirsagar SJ. Development and Validation of Analytical Method by RP-HPLC and Forced Degradation Studies of Tioconazole Drug. Asian Journal of Pharmaceutical Analysis. 2019; 9(4): 229-231. doi: 10.5958/2231-5675.2019.00039.5
29.    Khushbu KP, Arati MP, Patel CN. A new simple RP-HPLC Method development, Validation and Forced degradation studies of Bilastine.Asian Journal of Pharmaceutical Analysis. 2021; 11(3):183 doi: 10.52711/2231-5675.2021.00031.
30.    Varma BHR, Rao BS. Gas Chromatography-Head Space-Mass Spectrometry Sensor based Quality Control of Dobutamine Hydrochloride Bulk Material for a mutagenic impurity, 2-bromopropane. Research Journal of Chemistry and Environment. 2023; 27: 54-61.doi:10.25303/2702rjce054061
31.    Rajesh VB, Battula SR, Kapavarapu MVNR, Mandapati VR. A novel Rivaroxaban degradation impurity detection by RP-HPLC extraction by preparative chromatography, and characterization by LC-MS, NMR and FT-IR: Analysis of novel impurity in batch samples and tablets of Rivaroxaban. Rasayan Journal Chemistry. 2022; 15: 2373-2381. https://doi.org/10.31788/RJC.2022.1547008
32.    Rajesh VB, Sreenivasa RB, Maruthi VNRK, Varaprasad RM. Assessment of gas chromatography methodology approach for the trace evaluation of carcinogenic impurity. methyl chloride, in trimetazidine dihydrochloride. Annales Pharmaceutiques Francaises. 2023; 81: 64-73.doi:10.1016/j.pharma.2022.06.012
33.    Varma RB, Rao BS. Gas Chromatography-Head Space-Flame Ionization Sensor based assessment of four residuary solvents in rivaroxaban bulk medication. Research Journal of Pharmacy and Technology. 2022; 15: 5158-5163. doi:10.52711/0974-360X.2022.00868

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

1.3
2021CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank

Journal Policies & Information


Recent Articles




Tags


Not Available