Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF LORATADINE USING UVSPECTROPHOTOMETER

Prathap B.*, Arivazhagan M., Arikaran S., Arthi R., Arshad Khan M., Balajeevarshan KNR. and Mohamed Halith S.

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Abstract

The UV-Spectrophotometric method can be used for routine analysis of Loratadine in API and Pharmaceutical dosage form. Pharmaceutical analysis is mainly focused in drug analysis, raw material and pharmaceutical formulation involving the determination of active components, impurities, excipients, content uniformity, solubility, dissolution rate and stability. The spectrophotometric method were successfully developed for the determination by using INFRADIGI IR- 513C, solvent system was 0.1 N HCL, Ethanol, detection wavelength was 276nm. The analytical method was validated according to ICH guidelines (ICH, Q2(R1)). The linearity study for Loratadine was found in concentration range of 0.5-2.5μg/ml and correlation coefficient (r2) was found to be 0.999, The percentage mean recovery for Loratadine was found to be 96.83%. The precision study was precise, intermediate precision, and Method Precision. RSD% for intermediate precision was 1.4%. The %RSD method precision was found to be 0.4%. The degradation was determined by both analysed both drug solutions in the presence of acid, base, hydrogen peroxide, thermal and photosensitivity.

Keywords: Loratadine, Antihistamine, Uv-spectrophotometer, Validation method, Absorbance, ?max wavelength.