NOVEL RP-HPLC METHOD FOR THE ... - Ijsidonline.info

Validation of the MethodThamma Narendra Kumar et al., IJSID, 2011, 1 (3), 395-421Specificity: Specificity is the ability of the method to measure the analyte response in the presence of itsdegradants. The specificity of the developed method was carried in the presence of its degradants. Stress studieswere performed on dosage form to provide an indication of the stability-indicating property and specificity of theproposed method. Intentional degradation was attempted with stress condition of UV light (200 watts h/m 2 ), Sunlight (1.2 Million Lux Hours), Humidity (90% RH at 25°C about 7 days), Dry heat (105 o C), Acid (2N HCl), Base (2NNaOH) and Oxidation (5% H 2O 2) to evaluate the ability of the proposed method to separate Metformin from itsdegradation products. For heat, study period was 48 hrs whereas for hydrolytic, acid, base and oxidation studyperiod was about 1 hr. Peak purity test was carried out by using PDA detector in stress samples. In the stressedsamples % degradant products were calculated and reported in table-2.A study was conducted to demonstrate the effective separation of degradants from the active ingredient.Drug product and placebo were subjected to the following stress conditions to induce degradation.Table–2: Stress study conditions and resultsStress Study Stress Condition % DegradationAcid Hydrolysis 2N HCl solution for about 1 hr at 60°C 1.0Base Hydrolysis 2N NaOH solution for about 1 hr at 60°C 6.2Oxidation 5% H2O2 for 1 hr at 60°C 0.1Aqueous Hydrolysis Purified water for about 1 hr at 60°C 0.3Fluorescent Light Exposure Sun-light of 1.2 Million Lux Hours 0.3UV Light Exposure UV-light of 200 Watts h/m 2 1.1Thermal Dry heat at 105°C for 48 hrs 3.9Humidity 90% RH at 25°C for 7 days 4.6For active peak, peak purity was evaluated by using the Photodiode array detector and purity of peak in allstressed conditions was passed.Figure-14: Blank chromatogramInternational Journal of Science Innovations and Discoveries Vol 1, Issue 3, November-December 2011404