DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF OLMESARTAN MEDOXOMIL AND CHLORTHALIDONE IN COMBINED TABLET DOSAGE FORMS

Sonali Sangle, Padmanabh Deshpande*, Neha Shinde and Vishal Tayade

ABSTRACT

The present work describes development and validation of a new simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic (HPTLC) method for determination of Olmesartan medoxomil and Chlorthalidone in combined tablet dosage form. The chromatographic separation was carried out using aluminium plates precoated with silica gel 60F254 (10 × 10 cm) as stationary phase and Toluene: Ethyl acetate: Methanol (5: 3: 2, v/v/v) as mobile phase. Retention factors for Olmesartan medoxomil and Chlorthalidone were found to be 0.48±0.02 and 0.72±0.02, respectively. The wavelength selected for detection was 229 nm. Drug samples were subjected to different stress conditions like hydrolysis, oxidation, photolysis and thermal degradation. The developed method has been validated for linearity, accuracy, precision, limit of detection and limit of quantification and robustness, as per ICH guidelines. Results were found to be linear in the concentration range of 200-1200 ng band-1 for Olmesartan medoxomil and 125-750 ng band-1 for Chlorthalidone, respectively. The percentage drug contents obtained for Olmesartan medoxomil and Chlorthalidone were 99.71 and 100.45, respectively. The developed method can be used for the quantification of drugs in combined tablet dosage form as well as for routine analysis in quality control laboratories.

Keywords: Olmesartan medoxomil, Chlorthalidone, HPTLC, Stability Studies, Validation.