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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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  • 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