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Simultaneous Estimation of Cal DL-2-Hydroxy,4-methyl thio-butyrate and Ca-2-oxo3-phenyl Propionate in Alpha-Ketoanalogues Tablets by Validated RP-HPLC Method

1,2, 1, 2, 2, 3, 4

  1. 1Department of Pharmaceutical Analysis, School of Pharmaceutical Sciences, Siksha O Anusandhan (Deemed to be University), Bhubaneswar, Odisha, INDIA.
  2. 2Department of Pharmaceutical Chemistry, Bharat Technology, Beltala, Uluberia, Howrah, West Bengal, INDIA.
  3. 3Department of Pharmacology, Bharat Technology, Beltala, Uluberia, Howrah, West Bengal, INDIA.
  4. 4Department of Pharmaceutical Analysis. The Neotia University, School of Pharmacy, Sarisha, Diamond Harbour, West Bengal, INDIA.

CORRESPONDENCE

Prof. Dr. Anindya Bose

Department of Pharmaceutical Analysis, School of Pharmaceutical Sciences, Siksha O Anusandhan (Deemed to be University), Bhubaneswar, Odisha, INDIA.,

anindyabose_in@yahoo.com

Received: 03-08-2023; Accepted: 24-03-2024.

Volume 58, Issue 3 · pp. 925-930 · 2024 · DOI: 10.5530/ijper.58.3.101

ABSTRACT

Introduction: Alpha-Ketoanalogues is a dietary supplement drug containing Calcium-DL- 2-hydroxy-4-(methylthio) butyrate (CHMTB) and Calcium-2-oxo-3-phenyl propionate (COPP) for the management of chronic renal disease.Objectives: In this study, a simple RP-HPLC method has been developed to simultaneously determine Calcium-DL-2-hydroxy-4-(methylthio) butyrate (CHMTB) and Calcium-2-oxo-3-phenyl propionate (COPP) in Alpha-Ketoanalogues Tablets.Materials and Methods: The compounds were separated in a single run using a Waters XBridge 250 mm x 4.6 mm C18 column with 5μm particle size and 130 Å pore size. Elution was carried out via gradient mode with the UV detector wavelength set at 210 nm. The mobile phase selected was a binary mixture of ammonium hydrogen sulphate buffer (pH 7.0) and acetonitrile at a 1.0 mL/min flow rate.Results: The retention time of CHMB and COPP was found to be about 7 min and 20 min, respectively. The chromatographic method shows detector linearity in 50-150% of the operating range with the square of correlation coefficient at 0.9998 and 0.9999 for these two compounds, respectively. The parentage recovery of both CHMB and COPP was within 98-102% range. The method validation was carried out per the USP (chapter 1225) and ICH guidelines (Q2-R2). The developed method was found to be specific, precise, linear, robust, and accurate.Conclusion: This method could be utilized to assay tablet formulation of CHMB and COPP during the in-process and finished product quality control.

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    Panda, S., Bose, A., Debnath, B., Nath, R., Das, A., & Ghosh, S. (2024). Simultaneous Estimation of Cal DL-2-Hydroxy,4-methyl thio-butyrate and Ca-2-oxo3-phenyl Propionate in Alpha-Ketoanalogues Tablets by Validated RP-HPLC Method. Indian Journal of Pharmaceutical Education and Research, 58(3), 925-930. https://doi.org/10.5530/ijper.58.3.101

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    © 2024 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0