RP-HPLC Method Development and Validation of Labetalol HCl for Bulk and Pharmaceutical Formulations

Objective To develop an easy efficient and rapid analytical technique for the development and validation of Labetalol in dosage forms. Methods The drug was eluted isocratically using a Shimpack C18 4.6 x 250 mm 5mum column in mode using Acetonitrile and Phosphate buffer pH 6.5 6...

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Main Authors: Namratha NY, DeviReddy Prashanthi, Chaithanya MS, Veeresh Prabhakar Veerapur
Format: Article
Language:English
Published: Rajiv Gandhi University of Health Sciences 2025-01-01
Series:RGUHS Journal of Pharmaceutical Sciences
Online Access:https://journalgrid.com/view/article/rjps/12434436
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author Namratha NY
DeviReddy Prashanthi
Chaithanya MS
Veeresh Prabhakar Veerapur
author_facet Namratha NY
DeviReddy Prashanthi
Chaithanya MS
Veeresh Prabhakar Veerapur
author_sort Namratha NY
collection DOAJ
description Objective To develop an easy efficient and rapid analytical technique for the development and validation of Labetalol in dosage forms. Methods The drug was eluted isocratically using a Shimpack C18 4.6 x 250 mm 5mum column in mode using Acetonitrile and Phosphate buffer pH 6.5 6040 vv at 1 mLmin with 306 nm as detection wavelength at 3.3 min.Results This method showed a linear response for concentrations 10 to 50 mugmL with 0.9998 as correlation coefficient. The current method was validated in terms of system suitability specificity linearity precision accuracy LOD Limit of detec tion LOQ Limit of quantification and robustness. The recovery of Labetalol HCl was found to be 101.26. The percentage assay of Labetalol HCl present in the marketed formulation Labebet-100 mg was found to be 102.34. Conclusion Thus this proposed method can be successfully executed for the routine analytical work of Labeta lol HCl in bulk and tablet dosage forms in accordance with ICH Q2 R1 guidelines.
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issn 2249-2208
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publishDate 2025-01-01
publisher Rajiv Gandhi University of Health Sciences
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series RGUHS Journal of Pharmaceutical Sciences
spelling doaj-art-2a9bca977dc3458282c4ccb165fd88d02025-08-20T02:37:37ZengRajiv Gandhi University of Health SciencesRGUHS Journal of Pharmaceutical Sciences2249-22082025-01-0115210.26463/rjps.15_2_2RP-HPLC Method Development and Validation of Labetalol HCl for Bulk and Pharmaceutical FormulationsNamratha NYDeviReddy PrashanthiChaithanya MSVeeresh Prabhakar Veerapur Objective To develop an easy efficient and rapid analytical technique for the development and validation of Labetalol in dosage forms. Methods The drug was eluted isocratically using a Shimpack C18 4.6 x 250 mm 5mum column in mode using Acetonitrile and Phosphate buffer pH 6.5 6040 vv at 1 mLmin with 306 nm as detection wavelength at 3.3 min.Results This method showed a linear response for concentrations 10 to 50 mugmL with 0.9998 as correlation coefficient. The current method was validated in terms of system suitability specificity linearity precision accuracy LOD Limit of detec tion LOQ Limit of quantification and robustness. The recovery of Labetalol HCl was found to be 101.26. The percentage assay of Labetalol HCl present in the marketed formulation Labebet-100 mg was found to be 102.34. Conclusion Thus this proposed method can be successfully executed for the routine analytical work of Labeta lol HCl in bulk and tablet dosage forms in accordance with ICH Q2 R1 guidelines.https://journalgrid.com/view/article/rjps/12434436
spellingShingle Namratha NY
DeviReddy Prashanthi
Chaithanya MS
Veeresh Prabhakar Veerapur
RP-HPLC Method Development and Validation of Labetalol HCl for Bulk and Pharmaceutical Formulations
RGUHS Journal of Pharmaceutical Sciences
title RP-HPLC Method Development and Validation of Labetalol HCl for Bulk and Pharmaceutical Formulations
title_full RP-HPLC Method Development and Validation of Labetalol HCl for Bulk and Pharmaceutical Formulations
title_fullStr RP-HPLC Method Development and Validation of Labetalol HCl for Bulk and Pharmaceutical Formulations
title_full_unstemmed RP-HPLC Method Development and Validation of Labetalol HCl for Bulk and Pharmaceutical Formulations
title_short RP-HPLC Method Development and Validation of Labetalol HCl for Bulk and Pharmaceutical Formulations
title_sort rp hplc method development and validation of labetalol hcl for bulk and pharmaceutical formulations
url https://journalgrid.com/view/article/rjps/12434436
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AT chaithanyams rphplcmethoddevelopmentandvalidationoflabetalolhclforbulkandpharmaceuticalformulations
AT veereshprabhakarveerapur rphplcmethoddevelopmentandvalidationoflabetalolhclforbulkandpharmaceuticalformulations