Volume No. :   9

Issue No. :  2

Year :  2019

ISSN Print :  2231-5683

ISSN Online :  2231-5691


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Method Development and Validation of Spectroscopic Method for Content Analysis of Cefaclor with Stability Studies



Address:   Revathi R*,1, Ethiraj T2, Chandru S1, Dilip I1, Faisul Rahman S1
1Department of Pharmaceutical Analysis, The Erode College of Pharmacy, Erode, Tamilnadu.
2Department of Pharmaceutics, JKKMunirajahh Institute of Health Sciences College of Pharmacy, T.N.Palayam, Erode, Tamil Nadu.
*Corresponding Author
DOI No: 10.5958/2231-5691.2019.00012.1

ABSTRACT:
A simple, precise and stability indicating spectroscopic method was developed and validated for the content analysis of Cefaclor in the oral solid dosage forms. Proposed method was developed by measuring the absorbance of Cefaclor at 262.4 nm as ?max in aqueous medium. The beer’s law range was found to be 5-50 µg/mL with correlation co-efficient of 0.998. linear regression of absorbance on concentration gave the equation Y=0.021X + 0.008 with molar absorptivity and sandell’s sensitivity of 0.817 ×103 Lmol-1 cm-1 and 0.02792 µg/cm2/0.001 absorbance unit respectively. LOD and LOQ were found to be 1.0917 µg/mL and 3.3075 µg/mL for this proposed method and had been validated for precision accuracy as per Q2(R1) ICH guidelines. During the stability studies at various stress conditions, it was assessed that the drug was significantly degraded with alkaline hydrolysis when compared to other stressed condition. Then the validated method was successfully applied to the assay of Cefaclor in bulk and formulation, hence results were compared with reported method.
KEYWORDS:
Cefaclor, Validation, Stability studies, ICH guidelines, Stress condition.
Cite:
Revathi R, Ethiraj T, Chandru S, Dilip I, Faisul Rahman S. Method Development and Validation of Spectroscopic Method for Content Analysis of Cefaclor with Stability Studies. Asian J. Pharm. Res. 2019; 9(2): 75-79.
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