European Journal of Biomedical and Pharmaceutical Sciences

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF NISOLDIPINE (NISO) IN TABLET DOSAGE FORM

Patre Narendra G.*, Patil S. S. and Shivpuje Shivraj S.

ABSTRACT

A HPTLC method for the estimation of Nisoldipine (NISO) was developed using pre-coated silica gel F254 plates with chloroform: glacial acetic acid: methanol (8.5: 1:0.5 v/v) as mobile phase. The optimum wavelength for detection and quantitation was 227 nm. The retention factor was found to be 0.29 ± 0.008. NISO was subjected to stress test conditions like acid, alkali, neutral, oxidative, photolytic and thermal degradation. Amount of drug remaining after degradation study was observed 92.43, 82.66, 89.62, 86.72, 65.48 and 99.68% in acid, alkali, neutral, oxidative, photolytic and thermal degradation condition respectively. The method was validated for parameter such as linearity, precision, accuracy, range, specificity and robustness. Limit of detection and limit of quantification was found to be 20.60 ng and 62.42 ng respectively. The parentage recovery was found to be 100.56%. The linearity was established in the range of 100-1000 μg/ml with r2 0.996. This HPTLC method is sensitive, less time consuming than other chromatographic procedures.

Keywords: Nisoldipine, HPTLC, method development, validation, degradation studies.