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UV Spectrophotometric and stability indicating RP-HPLC methods for simultaneous estimation of Moxifloxacin HCl and Ketorolac tromethamine in bulk and ophthalmic dosage forms


Affiliations
1 Department of Pharmaceutical Analysis, Sri Vasavi Institute of Pharmaceutical Sciences, Tadepalligudem., India
2 Department of Pharmaceutical Analysis, K.G.R.L. College of Pharmacy, Bhimavaram., India
     

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It was the main goal of this study's research to develop simple UV-Spectrophotometric and Stability indicating RP-HPLC methods for the simultaneous estimation of Moxifloxacin HCl (MOX) and Ketorolac Tromethamine (KET) in bulk and ophthalmic dosage forms, as well as to conduct Forced Degradation experiments. When utilising linearity ranges between 1.0 and 9.0 g/ml for MOX and KET, correlation co-efficients >0.990 were used in the UV Spectrophotometry test results. Acetonitrile (40:60 v/v) was the solvent of choice. MOX and KET were discovered to have wavelengths of 295 nm and 316 nm, respectively. Researchers discovered that the isobestic point was located at 308 nm. Both medicines were separated using RP-HPLC on a SHISHEDO C18, 2504.6mm, 5 micron size column with a mobile phase made up of 40:60 v/v acetonitrile and water with flow rate of 0.9 ml/min and UV detection at 308 nm. Moxifloxacin Hcl and Ketorolac Tromethamine had retention durations of 2.080 minutes and 4.400 minutes, respectively. Moxifloxacin Hcl and Ketorolac Tromethamine have linearities of 1.0-6.0 g/ml and 1.0-6.0 g/ml, respectively. For linearity, recovery, limit of detection, and limit of quantification statistical validation was performed on the technique. Accuracy and precision were also evaluated. Analytes are well-resolved from degradation products when medicines are subjected to a variety of stresses, such as acidic or alkaline pH values, high oxidation or photo-stability temperatures, or a combination of these circumstances. The accuracy, precision, linearity, limit of detection, limit of quantification, and robustness of the two proposed techniques were effectively validated. This means that both Moxifloxacin HCl and Ketorolac Tromethamine may be estimated simultaneously in bulk and ophthalmic dose forms using these two techniques.

Keywords

Moxifloxacin HCl, Ketorolac Tromethamine, UV Spectrophotometry, ICH guidelines.
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  • Data base of Moxifloxacin HCl, compilation prepared by drug bank, http://www.drugbank.ca/drugs/DB01044.
  • Data base of Ketorolac tromethamine, compilation prepared by drug bank, http://www.rxlist.com/Ketorolac Tromethaminedrug.htm.
  • Santosh Gupta, Arora, R. Yadav. Quantitative Determination of Ketorolac Tromethamine from Eye Drop Formulation by UV Spectrophotometry, Asian Journal of Pharmaceutical Research and Development. 2014; 2(4):72-74.
  • Rajesh patel, K. Sayaendra, Shrivastava, B. Priya, Arun Patidar.UV Spetrophotometric Method for the Simultaneous Estimation of Moxifloxacin Hcl and Prednisolone Acetate from Eye Drop Formulation, International Journal of Pharmacy & Life Sciences.2011; 3(12): 2111-2114.
  • Vijaya Vichare, Vrushali Tambe, S V Joshi, S N Dhole. New Simultaneous UV-Visible Spectrophotometric Methods for Estimation of Ofloxacin and Ketorolac Tromethamine in Ophthalmic Dosage Form. Asian J. Pharm. Ana. 2013; 3(2):53-57.
  • V. S. Tambe, M. N. Deodhar, Vijayalakshmi Prakya. Validated Simultaneous UV Spectrophotometric Methods for estimation of Tramadol Hydrochloride and ketorolac Tromethamine in bulk and marketed Capsule Formulation. Asian J. Pharm. Ana. 2017; 7(4): 203-208.
  • Pavan P. Chintawar, Poonam N. Pawar, Minal T. Harde, Suhas V. Joshi, Praveen D. Chaudhari. Spectrophotometric Methods for Simultaneous Estimation of Moxifloxacin HCl and Ketorolac Tromethamine. Asian J. Research Chem. 2010; 3(3): 767-771.
  • Mukthinuthalapati Mathrusri Annapurna, Vellanki S. V. Sevyatha, Malineni Sushmitha. Simultaneous determination of Ketorolac tromethamine and Fluorometholone in Eye drops by spectrophotometry. Research J. Pharm. and Tech. 2017; 10(4): 1179-1183.
  • S.N. Kothawade, S.T. Deshpande, A.S. Lunkad, P.A. Dighe.Formulation and In-Vitro Characterization of Ketorolac Tromethamine Ophthalmic Inserts.Research J. Pharma. Dosage Forms and Tech. 2013; 5(6): 311-314.
  • S.K. Gupta, I.J. Singhvi. Sustained Ophthalmic Delivery of Moxifloxacin Hydrochloride from an pH Triggered in Situ Gelling System. Research J. Pharm. and Tech. 5(12): Dec. 2012; Page 1538-1542.
  • Sunkara Mrunal Chaithanya, Mukthinuthalapati Mathrusri Annapurna. Method Development and Validation of a new RPHPLC method for the simultaneous Assay of Ketorolac Tromethamine and Fluorometholone. Research J. Pharm. and Tech 2018; 11(7): 3119-3122.
  • N. Sunitha, Y. Sujitha, B. Thangabalan, S. Manohar Babu.Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Ketorolac Tromethamine and Olopatadine Hydrochloride in Pure and Pharmaceutical Formulation. Res. J. Pharm. Dosage Form. and Tech. 2014; 6(1): 37-43.
  • V. Suma kanagu, M. Janardhan:, Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Moxifloxacin in Moxifloxacin Hcl tablets 400 mg. International Journal of Pharmaceutical Invention. 2012; 2(7): 27-31.
  • Prakash B. Modi, Ajay S.Vairale, P. Sivaswaroop. Development and Validation of HPLC method for determination of Ketorolac tromethamine residues on the surface of manufacturing equipment.
  • Asian J. Research Chem. 2012; 5(2):259-264.
  • Nadeem Ahmed Farooqui, Ravindra Pal Singh, Mousumi Kar, Mahavir Chhajed, Jacky Dumbwani. Development of Rapid and Sensitive Reverse Phase High Performance Liquid Chromatography Method for Estimation of Ketorolac Tromethamine in Proniosomal Gel. Asian J. Pharm. Ana. 2018; 8(3): 157-163.
  • Dharti Patel, Mehul Patel, Ketan Patel. Simultaneous RP-HPLC Estimation of Moxifloxacin Hydrochloride and Ketorolac Tromethamine in Ophthalmic Dosage Forms. Asian J. Research Chem. 2012; 5(5): 697-699.
  • R. Bhagyashree, L. Dhumal, P. Kishore. Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Moxifloxacin in Moxifloxacin Hcl Tablets, International Journal of Pharmaceutical Invention.2012; 2(7): 11-24.
  • G. Sunil, M. Jambulingam, S. Ananda Thangadurai, D.Kamalakannan, R. Sundaraganapathy, C. Jothimanivannan.Development and Validation of Ketorolac Tromethamine in Eye Drop Formulation by RP-HPLC method, Arabian Journal of Chemistry. 2012; 3(7):21-26.
  • Syed Naeem Razzaq, Islam Ullah Khan, Irfana Mariam and Syed Saleem Razzaq:, Stability Indicating HPLC Method for the Simultaneous Determination of Moxifloxacin and Prednisolone in Pharmaceutical Formulations, Chemistry Central Journal. 2012; 4(7): 1-4.
  • S. Chaudhari, Dhiraj A. Khairnar, Sanjay P. Anantwar:, Method Development and Validation of Ketorolac Tromethamine in Tablet Formulation by RP- HPLC method, Der Pharmacia Lettre. 2014; 6(6): 335-341.
  • Ch. Rambabu, B. Koteswara, G. Ramu, I. Jyothsna Kumari:, A Novel Stability Indicating RP- HPLC Method for the Determination of Ketorolac Tromethamine in Pharmaceutical Formulations, Asian Journal of Pharmaceutical and Clinical Research. 2015; 8(2): 135-139.
  • I. Ramzia, A. El-Bagarya, Marwa Fouada, M. Fatma-Elzhraa, M.Khaled and Emad Hussien:, Derivative and Derivative Ratio Spectrophotometric Methods for the Simultaneous Determination of Moxifloxacin Hydrochloride with Ketorolac Tromethamine and Ciprofloxacin hydrochloride with Dexamethasone Sodium Phosphate in Bulk and Eye Drop Formulation, Journal of Chemical and Pharmaceutical Research. 2013; 5(10): 155-164.
  • Tapas Majumder, Sarbojit Kundu, Subrata Kumar Ray and Prasanta Kumar Barat:, Development and Validation of a HPLCUV Method for Simultaneous Determination of Moxifloxacin Hydrochloride and Ketorolac Tromethamine in Ocular Formulation, International Journal of Pharmaceutical Sciences and Research. 2012; 5(7): 1.54-3.72.
  • Dharti patel, Mehul Patel, Ketan Patel:, Simultaneous RP-HPLC Estimation of Moxifloxacin Hydrochloride and Ketorolac Tromethamine in Ophthalmic Dosage Forms, Asian Journal of Research Chemistry. 2012; 5(5):698-700.
  • Muhammad Ashfaq, Syed Naeem Razzaq, Islam Ullah Khan, Irfana Mariam:, Stability Indicating HPLC Method for Simultaneous Determination of Moxifloxacin Hydrochloride and Ketorolac Tromethamine in Pharmaceutical Formulations, Quim.Nova. 2013; 35(6):100-404.
  • B. Davej, P. J. Patel:, A Validated Stability-Indicating High Performance Liquid Chromatographic Method for Moxifloxacin Hydrochloride and Ketorolac Tromethamine Eye Drops and its application in pH dependent degradation kinetics, Chron Young Sciences. 2013;4(4): 24-31.
  • P. Sunil Kumar Chaitanya, P. Laksmi , K. Deepthi Reddy and Jomol Joseph:, Development and Validation of a Liquid Chromatographic Method for the Simultaneous Estimation of Moxifloxacin and Keterolac in Opthalmic Dosage Form, Der Pharmacia Sinica.2014;6(4): 83-90.
  • Shahana Begum, K. Divya Bharathi, V. Laxmikanth and G. Tulja Rani. A Validated RP- HPLC Method for Simultaneous Estimation of Moxifloxacin Hydrochloride and Ketorolac Tromethamine in Ophthalmic Dosage Form, Der Pharmacia Lettre.2014; 6(8):335-341.
  • S. Bansode, Chetan Singh Chauhan, Ravindra Kamble, Preeti Gopaliya, Chatrapal Singh: Method Development and Validation of Quantitative Analytical Method for Moxifloxacin Hcl and Ketorolac Tromethamine Combination in Pharmaceutical Dosage Form by RP-HPLC, World Journal of Pharmacy and
  • Pharmaceutical Sciences.2015; 4(3): 1402-1408.
  • Parimi H, Bolla C, Gandhi BM, Vatchavai BR, Kamatham SS, Kolli S. Method Development and Validation of UV Spectroscopic and Stability Indicating RP-HPLC Method for Simultaneous
  • Estimation of Moxifloxacin HCl and Ketorolac tromethamine in Bulk and Ophthalmic Dosage Forms. Indian Drugs. 2017; 54 (4):38-46.
  • R. Raghavi, D. Saravanan, A. Maheswaran, P. Divakar. Analytical method development and validation for simultaneous estimation of moxifloxacin hydrochloride and ketorolac tromethamine by using
  • RP-HPLC. International Journal of Research in Pharmaceutical sciences and Technology. 2020; 2(1), 25-31.
  • ICH Harmonized Tripartite Guideline: Validation of Analytical Procedures: Q2(R1), International Conference on Harmonization, Geneva (2005), 1-13.
  • ICH Harmonized Tripartite Guideline:, Stability Testing of New Drug Substances and Products: Q1A(R2), International Conference on Harmonization, Geneva (2003), 1-18.

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  • UV Spectrophotometric and stability indicating RP-HPLC methods for simultaneous estimation of Moxifloxacin HCl and Ketorolac tromethamine in bulk and ophthalmic dosage forms

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Authors

Alluri Pavani Gayatri
Department of Pharmaceutical Analysis, Sri Vasavi Institute of Pharmaceutical Sciences, Tadepalligudem., India
Kolli Srinivas
Department of Pharmaceutical Analysis, Sri Vasavi Institute of Pharmaceutical Sciences, Tadepalligudem., India
Kavala Nageswara Rao
Department of Pharmaceutical Analysis, K.G.R.L. College of Pharmacy, Bhimavaram., India

Abstract


It was the main goal of this study's research to develop simple UV-Spectrophotometric and Stability indicating RP-HPLC methods for the simultaneous estimation of Moxifloxacin HCl (MOX) and Ketorolac Tromethamine (KET) in bulk and ophthalmic dosage forms, as well as to conduct Forced Degradation experiments. When utilising linearity ranges between 1.0 and 9.0 g/ml for MOX and KET, correlation co-efficients >0.990 were used in the UV Spectrophotometry test results. Acetonitrile (40:60 v/v) was the solvent of choice. MOX and KET were discovered to have wavelengths of 295 nm and 316 nm, respectively. Researchers discovered that the isobestic point was located at 308 nm. Both medicines were separated using RP-HPLC on a SHISHEDO C18, 2504.6mm, 5 micron size column with a mobile phase made up of 40:60 v/v acetonitrile and water with flow rate of 0.9 ml/min and UV detection at 308 nm. Moxifloxacin Hcl and Ketorolac Tromethamine had retention durations of 2.080 minutes and 4.400 minutes, respectively. Moxifloxacin Hcl and Ketorolac Tromethamine have linearities of 1.0-6.0 g/ml and 1.0-6.0 g/ml, respectively. For linearity, recovery, limit of detection, and limit of quantification statistical validation was performed on the technique. Accuracy and precision were also evaluated. Analytes are well-resolved from degradation products when medicines are subjected to a variety of stresses, such as acidic or alkaline pH values, high oxidation or photo-stability temperatures, or a combination of these circumstances. The accuracy, precision, linearity, limit of detection, limit of quantification, and robustness of the two proposed techniques were effectively validated. This means that both Moxifloxacin HCl and Ketorolac Tromethamine may be estimated simultaneously in bulk and ophthalmic dose forms using these two techniques.

Keywords


Moxifloxacin HCl, Ketorolac Tromethamine, UV Spectrophotometry, ICH guidelines.

References