European Journal of Biomedical and Pharmaceutical Sciences

STABILITY INDICATING ASSAY METHODS FOR SIMULTANEOUS ESTIMATION OF AMOXICILLIN TRIHYDRATE AND CLOXACILLIN SODIUM IN COMBINED CAPSULE DOSAGE FORM BY UV -SPECTROPHOTOMETRIC METHOD

Wadher Shailesh J.*, Patwekar Shailesh L., Shivpuje Shivraj S., Khandre Supriya S., Lamture Sima S., Manisha P. Puranik

ABSTRACT

Two simple, accurate, rapid, precise, and economical methods were developed and validated for the estimation of amoxicillin trihydrate and cloxacillin sodium in capsule dosage form. Method A is simultaneous equation method, wherein wavelengths selected for amoxicillin trihydrate is 246.4 nm, and cloxacillin sodium is 217 nm. Method B is absorbance ratio method wherein wavelength selected for isobestic point 238.8 nm. In both methods Amoxicillin trihydrate and cloxacillin sodium followed the linearity concentration range 5-30 μg/ml for both. Standard calibration curve for amoxicillin trihydrate and cloxacillin sodium with correlation coefficient (r2) value is 0.999 for amoxicillin trihydrate and 0.995 for cloxacillin sodium in method A, whereas 0.998 for amoxicillin trihydrate and 0.996 for cloxacillin sodium in method B. The proposed methods were validated according to ICH guidelines in terms of linearity, accuracy, precision, LOD and LOQ. Percentage assay was found in the range 99.66-100.22 %. In precision % RSD was found to be < 2% for both. The mean percentage recovery was found to be in the range 98.35-100.43 %. LOD and LOQ values were 0.216 μg/ml and 0.657 μg/ml for amoxicillin trihydrate and 0.086 μg/ml and 0.260 μg/ml for cloxacillin sodium in method-I, whereas 0.132 μg/ml and 0.402 μg/ml for amoxicillin trihydrate and 0.160 μg/ml and 0.487 μg/ml for cloxacillin sodium in method-II respectively. Degradation studies were carried under condition of acid, base, neutral hydrolysis, oxidative, photolysis, and thermal degradation.

Keywords: Amoxicillin trihydrate, cloxacillin sodium, simultaneous equation method, absorbance ratio method, UV spectroscopy, stability indicating assay method.