Stability Indicating HPTLC Method Development and Validation for Estimation of Nortriptyline and Pregabalin in Tablet Dosage Form Ghogare Jyoti D.*, Panchal Pranita P., Rathod Sayali P., Jadhao U. T. Department of Pharmaceutical Quality Assurance, SVP College of Pharmacy (B. Pharmacy), Hatta Tq. Basmat, Dist - Hingoli *Corresponding Author E-mail: jyotighogare8275@gmail.com
Online Published on 03 October, 2023. Abstract Chromatography is non-destructive procedure for resolving a multi-component mixture of solids, gases, Liquids. HPTLC is use of validated methods for qualitative and quantitative analysis. HPTLC is playing an important role in analytical world and a complementary method for HPLC. The analytical method was evaluated by using parameters such as Linearity, Precision, Accuracy, Limit of detection and Limit of quantification, Specificity, Robustness. In this method 100ng µL-1 and 750ng µL-1 volume of standard stock solutions of Nortriptyline and Pregabalin were taken, respectively. The mobile phase contains Toluene: Ethyl acetate: Methanol (6: 2: 1, v/v/v). Standard stock solutions were applied by over spotting on HPTLC plate with the help of CAMAG 100µl sample syringe, Linomat 5 sample applicator. The development chamber was saturated for 15 min. The plate was scanned at 210nm. The retention factors of PREGA and NORT were found to be PREGA: 0.48±0.03, NORT: 0.70±0.07. The % drug content (mean±S.D.) were found to be 99.32±1.39 for NORT and 99.75±1.15 for PREGA. The results of stress degradation studies revealed that NORT was prone to hydrolysis, oxidative, thermal and photolytic degradation whereas PREGA was found susceptible to hydrolysis, oxidative, thermal degradation but stable under photolytic stress conditions. Top Keywords HPTLC, Nortriptyline, Pregabalin, Method development, ICH guidelines. Top |