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