Volume : 10, Issue : 12, December – 2023
Title:
STABILITY INDICATING HPTLC METHOD FOR DETERMINATION TIMOLOL MALEATE IN BULK DRUG & ITS FORMULATION
Authors :
Adawale Sanjana Sanjay*, Dr.Dhumal . P. B, Dr. Sameer Shafi, Dr. Vishweshwar Dharashive.
Abstract :
Timolol was the first β blocker to be used as an anti-glaucoma agent and to date remains as the standard because none of the newer β blockers were found to be more effective. A new, simple, precise, accurate and sensitive High Performance Thin Layer Chromatographic method has been developed for the estimation of Timolol Maleate in bulk and marketed ophthalmic formulation. Chloroform: Methanol: Ammonia (9:1:0.1 v/v/v) was selected as a mobile phase. The determination was made at 296 nm for Timolol Maleate over the concentration range of 100-1000 ng/spot. The Correlation Coefficient R2 in calibration curve was found to be 0.9949. The Rf value was found to be 0.53 ± 0.027. The intra-day and inter-day relative standard deviations are in the range 0.55-0.99 % and 0.47-1.85 % respectively. The validation of method was carried out as per ICH Guidelines. The stability-indicating ability and specificity of the proposed method forced degradation studies were performed. Hydrolysis under acidic, alkaline & neutral & oxidative & thermal and photolytic degradation studies were conducted on Timolol Maleate. No interference of additives, matrix etc. is encountered in these methods. The drug showed 10- 20 % degradation in acidic, alkali, neutral, oxidation, thermal & Photolytic conditions. stability indicating Statistical analysis proved that these methods are reproducible, selective for the analysis of Timolol Maleate in bulk drug and in its ophthalmic formulations and can be used to determine the purity of the drug even in presence of excipients and related impurities.
Keywords: Timolol Maleate, High Performance Thin Layer Chromatographic, Validation, Degradation.
Cite This Article:
Please cite this article in press Adawale Sanjana Sanjay et al., Stability Indicating HPTLC Method For Determination Timolol Maleate In Bulk Drug & Its Formulation , Indo Am. J. P. Sci, 2023; 10 (12).
Number of Downloads : 10
References:
1) ICH, Q2 (R1), Validation of Analytical Procedures: Text and Methodology, ICHHarmonizedTripartite Guidelines, Geneva,(2005).
2) FDA, Guidance for Industry: Bio analytical Method Validation. US Departmentof Health and Human Services, Food and Drug Administration, Centre for DrugEvaluation and Research (CDER), and Centre for Veterinary Medicine (CVM),(2001).
3) http://www.who.int/governance/eb/who_constitution_en.pdf (Accessed on 6thApril2017)
4) S.Gorog,J.Pharm. Biomed.Anal.,48 (2008)247–253.
5) S Ahuja and S Scypinski, Handbook of Modern Pharmaceutical Analysis,SeparationScienceandTechnology,AcademicPress,USA(2011).
6) M. R. Siddiqui, Z. A. AlOthman, N. Rahman, Arab. J. Chem., 10 (2017) S1409–S1421.
7) J. Schappler, V. Gonzalez-Ruiz, S. Rudaz, CE-MS in Drug Analysis andBioanalysis, In G. de Jong ed. Capillary Electrophoresis – Mass Spectrometry(CE-MS): Principles and Applications, John Wiley & Sons, New Jersey, (2016),p. 129-158
8) R.W.LeeandL.Goldman,TechnicalBrief,Particlesciences,PA,USA,vol.5(2009)1-2.
9) D.Guillarme,J.Schappler,J.Boccard,J.L.Veuthey,S.Rudaz,Chimia.66(2012)330-334.
10) GorogS,J. Pharm. Biomed. Anal. 36(2005)931-937.
11) JErmer, J.Pharm. Biomed. Anal.24 (2001)755–767.
12) I. Bak, Modern analytical techniques in the pharmaceutical and bioanalysis,University of Debrecen Medical and Health Science Center Faculty ofPharmacy Department of Pharmacology Pharmacutical and bioanalyticaldivision,Hungary,(2011).
13) A.M. Sameer, K. AbdulrahmanBasavaiah, 2011. Chem. Ind. Chem. Eng. Q. 17(2011)173–178.
14) N. Matei, S. Birghila, V. Popescu, S. Dobrinas, A. Soceanu, C. Oprea, V.Magearu,Rom. J. Phys.53 (2008)343–351.
15) E. Rutkowska, K. Pajak and K. Jozwiak, Acta. Pol. Pharm. Drug. Res., 70(2013)3-18.