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Asian Journal of Pharmaceutical Research
Year : 2019, Volume : 9, Issue : 2
First page : ( 75) Last page : ( 79)
Print ISSN : 2231-5683. Online ISSN : 2231-5691.
Article DOI : 10.5958/2231-5691.2019.00012.1

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

Ethiraj T.1, Revathi R1,*, Ethiraj T2,*, Chandru S1,*, Dilip I1, Rahman S Faisul1

1Department of Pharmaceutical Analysis, The Erode College of Pharmacy, Erode, Tamilnadu

2Department of Pharmaceutics, JKK Munirajahh Institute of Health Sciences College of Pharmacy, T.N. Palayam, Erode, Tamil Nadu

*Corresponding Author E-mail: revathethiraj@gmail.com

Online published on 3 July, 2019.

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 λmax 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.

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Keywords

Cefaclor, Validation, Stability studies, ICH guidelines, Stress condition.

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