A Validated Stability-Indicating High-Performance Thin-Layer Chromatographic Method for the Analysis of Pitavastatin in Bulk Drug and Tablet Fomulation Rode Vanita P.*, Tajne Madhukar R. Department of Pharmaceutical Sciences, Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur-440 033 (MS) India *Corresponding Author E-mail: vanitaashtankar10@gmail.com
Online published on 2 June, 2018. Abstract The objective of the present research work is developing a simple, precise, and accurate stability-indicating normal-phase HPTLC method for estimation of Pitavastatin in the bulk drug and tablet formulation. Chromatography was performed on the plates precoated with silica gel 60F254 using toluene: methanol 8: 2 (v/v) as a mobile phase. Densitometric quantification was performed at 245 nm by reflectance scanning. The retardation factor of Pitavastatin was 0.50 ± 0.02. Validation of the method in accordance with ICH guidelines yielded good results for range, linearity, precision, accuracy, specificity and robustness. The data of linear regression analysis indicated a good linear relationship over the range of 50–400 ng/band concentrations with correlation coefficient 0.997. The limits of detection and quantitation were found to be 1.05 and 3.21 resp. Results from analysis of a commercial tablet formulation was 99.12 ± 1.58%. The method precision for the determination of assay was below 2.0%RSD. The percentage recoveries of active pharmaceutical ingredient (API) from dosage forms ranged from 99.27% to 101.87%. Stress testing of Pitavastatin was carried out according to the international conference of harmonization (ICH) guideline Q1A (R2). The drug was subjected to acid, base, neutral hydrolysis, oxidation, thermal degradation and photolysis which enabled separation and detection of degradation products from acidic, basic, neutral and oxidation stress. No degradation products were obtained after photo and dry heat stress condition. Top Keywords HPTLC-densitometric, Pitavastatin, Stress degradation, Stability indicatin. Top |