Development and Validation of Stability-Indicating Liquid Chromatographic Methods For Different Classes of Drug Substances |

ABSTRACT:

A stability-indicating high-performanceliquid chromatographic method was developed and validated for the determinationof Letrozole in tablet dosage forms. Reversed-phase chromatography wasperformed on Shimadzu Model LC-Class-Vp with Lichrocart/Lichrosphere 100 C-18(250 mm 4.6 mm, 5 mm particle size) column with methanol: tetra butyl ammoniumhydrogen sulfate (80:20V/V) as mobile phase at a flow rate of 1 mL/min with UVdetection at 240 nm. Linearity was observed in the concentration range of0.5–150 mg/mL (R2 ¼0.9998) with regression equation y¼102582xþ43185. The limitof quantization (LOQ) and limit of detection (LOD) were found to be 0.043 and0.012 mg/mL respectively. The forced degradation studies were performed byusing HCl, NaOH, H2O2, thermal and UV radiation. Letrozole is more sensitivetowards alkaline conditions and very much resistant towards acidic, oxidativeand photolytic degradations. The method was validated as per ICH guidelines.The RSD for intra-day (0.78–0.97) and inter-day (0.86–0.96) precision werefound to be lesser than 1%. The percentage recovery was in good agreement withthe labeled amount in the pharmaceutical formulations and the method is simple,specific, precise and accurate for the determination of Letrozole inpharmaceutical formulations.