HPTLC Method Development and Validation for Nortriptyline Hydrochloride in Bulk and it’s Tablet

The simple, accurate, precise and sensitive High Performance Thin Layer Chromatography (HPTLC) method was developed and validated. The stationary phase used was precoated Silica gel F254 plates. The mobile phase used for method development contains methanol: ethyl acetate: ammonia (6: 4: 0.2 v/v). From the overlain spectra of standard and tablet the detection wavelength of 245 nm was selected. The validation parameters like linearity, precision, accuracy, limit of detection, limit of quantification and robustness were performed. For the linearity concentration range selected was 100-500 ng/band. The coefficient of regression (R2) was found to be 0.9900. The percent Relative Standard Deviation (%RSD) for intraday and interday precision study was found to be 0.3301-1.9046%. The % recovery was performed to study accuracy and the results were found to be 98.70-100%. The limit of detection and limit of quantitation was found to be 527.04 and 1597.45 ng/band. The robustness of the method was studied by making deliberate changes in the mobile phase composition and saturation time, the %RSD was found to be 0.9137 and 1.0869. The forced degradation study was performed in acidic, basic, oxidative and neutral conditions. The degradants were observed. The method was validated as per ICH guidelines and developed method can be used for routine analysis in quality control laboratories.