Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Lorcaserin Hydrochloride in Bulk and Tablet Dosage Form

In the current study a simple, precise, sensitive and accurate reversed phase liquid chromatography method was developed for the analysis and estimation of Lorcaserin HCL in bulk and tablet dosage form. The present study of Lorcaserin HCL was achieved by using Cosmosil C18 (250nm×4.6ID, Particle Size: 5 Micron) Column with mobile phase Methanol:10mM KH2PO4 Buffer (70:30) pH:3 at a flow rate 0.8ml/min with UV detection at 222nm. The retention time for Lorcaserin HCL was found to be 5.108 min. In Linearity the correlation coefficient (R2) for Lorcaserin HCL was found to be 0.9995, slope is 42071 and intercept was found to be 21966 which are well within the acceptance criteria. The mean percent recovery for Lorcaserin HCL at three different levels for 50%, 100%, and 150% was found to be 100.65%, 98.84% and 100.34%. The %RSD (NMT 2%). In precision study interday (RSD is 0.26%) and intraday (RSD is 0.29%) are found.  Forced degradation experiments was carried out by exposing standard form of Lorcaserin HCL for Acid-base hydrolytic, Oxidative, photolytic and thermal stress conditions. The method has been validated by System suitability parameters, Linearity, Accuracy and Percent recovery, Precision, Ruggedness, Robustness, LOD and LOQ. Keywords: Lorcaserin hydrochloride, RP-HPLC, Validation

Stability-Indicating Reverse-Phase High-Performance Liquid Chromatographic Method Development and Validation of Lamotrigine in Bulk and Pharmaceutical Dosage Form

In the current study, analytical method has been validated by system suitability parameters, linearity, accuracy and percent recovery, precision, ruggedness, robustness, limit of detection, and limit of quantification. The present study of lamotrigine was achieved using Cosmosil C18 (250 nm×4.6 ID, particle size: 5 Micron) Column with mobile phase methanol: water (60:40) pH: 3 at a flow rate 0.8 ml/min with UV detection at 308 nm. The retention time for lamotrigine was found to be 4.979 min. In linearity, the correlation coefficient (R2) for lamotrigine was found to be 0.999, slope is 39,801, and intercept was found to be 51,862 which are well within the acceptance criteria. The mean percent recovery for lamotrigine at three different levels for 50%, 100%, and 150% was found to be 99.28%, 99.30%, and 100.40%. The % RSD should not more than 2%. In precision study, interday (RSD is 0.41%) and intraday (RSD is 0.26%) are found. Forced degradation experiments were carried out by exposing standard form of lamotrigine for acid-base, oxidative, photolytic, and thermal stress conditions. Hence, the developed method is accurate, precise, repeatable, and reproducible and can be used for routine analysis of lamotrigine