Research Journal of Pharmacy and Technology

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Development and Validation of Analytical Method for Estimation of Cetirizine Hydrochloride and Phenylephrine Hydrochloride in Pharmaceutical Formulation


Affiliations
1 Department of Quality Assurance, School of Pharmacy, Swami Ramanand Teerth Marathwada University, Vishnupuri, Nanded-431606, (M.S.), India
2 Department of Chemistry, Sri Krishnadevaraya University, Ananthapuramu-515003, Andhra Pradesh, India
     

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Analytical method using Fourier transform Infrared Spectroscopy was developed and validated for estimation of cetirizine hydrochloride and phenylephrine hydrochloride in their pharmaceutical formulation. The solid-state samples were prepared by dilution in dry potassium bromide and were analyzed by FTIR Spectrophotometer. A linear relationship for the carbonyl peak area centered around 1741cm-1 was observed in the range of 0.2-1.2% w/w with good correlation coefficient 0.997 for the cetirizine hydrochloride and for the hydroxyl peak area centered around 3419 cm-1 was observed in the range of 0.4-2.4% w/w with good correlation coefficient 0.998 for phenylephrine hydrochloride. The developed method was validated as per ICH guidelines.In addition to this the stability study is carried out by thermal exposure, photolytic exposure and sunlight exposure.

Keywords

Cetirizine Hydrochloride, Phenylephrine Hydrochloride, FT-IR, Method Validation and ICH Guideline.
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  • Development and Validation of Analytical Method for Estimation of Cetirizine Hydrochloride and Phenylephrine Hydrochloride in Pharmaceutical Formulation

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Authors

T. M. Kalyankar
Department of Quality Assurance, School of Pharmacy, Swami Ramanand Teerth Marathwada University, Vishnupuri, Nanded-431606, (M.S.), India
S. J. Wadher
Department of Quality Assurance, School of Pharmacy, Swami Ramanand Teerth Marathwada University, Vishnupuri, Nanded-431606, (M.S.), India
M. R. Bodhankar
Department of Quality Assurance, School of Pharmacy, Swami Ramanand Teerth Marathwada University, Vishnupuri, Nanded-431606, (M.S.), India
K. Anitha
Department of Chemistry, Sri Krishnadevaraya University, Ananthapuramu-515003, Andhra Pradesh, India

Abstract


Analytical method using Fourier transform Infrared Spectroscopy was developed and validated for estimation of cetirizine hydrochloride and phenylephrine hydrochloride in their pharmaceutical formulation. The solid-state samples were prepared by dilution in dry potassium bromide and were analyzed by FTIR Spectrophotometer. A linear relationship for the carbonyl peak area centered around 1741cm-1 was observed in the range of 0.2-1.2% w/w with good correlation coefficient 0.997 for the cetirizine hydrochloride and for the hydroxyl peak area centered around 3419 cm-1 was observed in the range of 0.4-2.4% w/w with good correlation coefficient 0.998 for phenylephrine hydrochloride. The developed method was validated as per ICH guidelines.In addition to this the stability study is carried out by thermal exposure, photolytic exposure and sunlight exposure.

Keywords


Cetirizine Hydrochloride, Phenylephrine Hydrochloride, FT-IR, Method Validation and ICH Guideline.

References