Development and Validation of Stability Indicating RP-HPLC Method for Assay and Dissolution of an Anti-psychotic drug in its tablet Dosage Form

Abstract

A new, simple, accurate, precise, rapid and selective stability indicating reverse-phase high performance liquid chromatography (RP-HPLC) method has been developed according to ICH guidelines and validated for quantification of An Anti-Psychotic Drug X from its tablet dosage formulation as well as for dissolution according to US-FDA guidelines for industry. The chromatographic method is based on RP-HPLC using Inertsil ODS (250×4.6 mm) 5μ particle size column. The separation in the presence of all the process impurity peaks was achieved by using isocratic elution of Water: ACN (65:35) with OPA at flow rate 2.0 mL/min and UV detection at 230 nm with the total run time of 10 min, at 40°C. Stability indicating capability is established by forced degradation experiment of Drug X with acid, alkali, oxidation, thermal and photo degradation conditions. The peak of the Drug X was found to be of acceptable peak purity index without any interference. The dissolution method employs of USP-Type II (paddle type) apparatus with agitation of 50 RPM and 900 ml of Mcillavine Buffer for one unit of Tablet dosage form of Drug X. The drug showed more than 95% release in 60 minutes. The detection was done by same RP-HPLC method developed for the assay. The linear regression analysis for assay method showed linear relationship between 25-75μg/mL with the linearity equation y = 10393x + 11587 with the correlation co-efficient of 0.9999. The linear regression analysis for dissolution method showed linear relationship with concentration range of 20-105μg/mL, linearity equation y = 10393x + 11587 and the correlation co-efficient of 0.9997. The method is validated for specificity, accuracy, precision, linearity, repeatability and robustness as per ICH guideline Q2 (R1) for method validation. The limit of detection and quantitation were found to be 0.475μg/ml and 1.440μg/ml for assay method. % Assay of tablet dosage form was found 99.47 % and % release obtained at the end of dissolution was 100.30%.The drug passed the peak purity index and free from interference from any degradation products, the developed RP-HPLC method can be employed as a stability indicating method for routine analysis of drug in various quality control laboratories.