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Eco-Friendly and Stability Indicating Spectroscopic Methods for Cinacalcet Hydrochloride: Method Development, Validation, and Application in Its Pharmaceutical Formulations
Abstract
The present paper explains the development and validation of four new eco-friendly and stabilityindicating spectroscopic methods of estimating a calcimimetic drug, i.e., cinacalcet hydrochloride (CIN), in its different pharmaceutical formulations. In these methods, the response of the standard solution is measured in 0.1N HCl as a diluent (nonhazardous) at 279, 294, and 299 nm for UV, first-, and second-order derivative spectrophotometric tools, respectively. The AUC-spectrophotometric technique is carried out by calculating the area under the curve (AUC) between the wavelength regions ranging from 266 to 286 nm. The linearity graph of the methods is plotted by taking response [Absorbance/(dA/dλ)/(d2A/dλ2) or AUC] values against the concentration and shows that the drug obeys Beer’s law within the concentration range 2.5 to 200 μg/mL for all the methods. The drug is exposed to various stress conditions as recommended by the ICH Q1A-Q1E guideline. The different method validation parameters are within the acceptable limit as per the ICH Q2R(1) guideline. The greenness profile of the developed UV spectroscopic tools is evaluated using the National Environmental Methods Index, the Analytical Eco-Scale, and the Analytical GREEnness (AGREE) metric approach. All approaches prove the greenness of the methods concerning solvent, chemicals, energy consumed, and waste produced. Eco-friendly spectroscopic methods can determine the quantity of CIN in various pharmaceutical dosage forms without influencing the environment and analysts.
Keywords
cinacalcet hydrochloride,
stress degradation study,
eco-friendly,
AGREE,
Analytical EcoScale,
national environmental methods index
Supporting agencies: The authors are grateful to the Roland Institute of Pharmaceutical Sciences, Berhampur-10, Odisha, India, for providing the financial and research facilities.
About the Authors
S. K. Acharjya
Roland Institute of Pharmaceutical Sciences, Dept. of Pharmaceutical Analysis and Quality Assurance
India
India
Odisha
N. K. Kumar
Roland Institute of Pharmaceutical Sciences, Dept. of Pharmaceutical Analysis and Quality Assurance
India
India
Odisha
S. K. Dash
Roland Institute of Pharmaceutical Sciences, Dept. of Pharmaceutical Analysis and Quality Assurance
India
India
Odisha
A. Chakraborty
Roland Institute of Pharmaceutical Sciences, Dept. of Pharmaceutical Analysis and Quality Assurance
India
India
Odisha
C. N. Patra
Roland Institute of Pharmaceutical Sciences, Dept. of Pharmaceutical Analysis and Quality Assurance
India
India
Odisha
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Review
For citations:
Acharjya S.K., Kumar N.K., Dash S.K., Chakraborty A., Patra C.N. Eco-Friendly and Stability Indicating Spectroscopic Methods for Cinacalcet Hydrochloride: Method Development, Validation, and Application in Its Pharmaceutical Formulations. Zhurnal Prikladnoii Spektroskopii. 2023;90(1):126. (In Russ.)
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