A STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF CLOZAPINE BY UV SPECTROSCOPIC METHOD IN BULK AND TABLET DOSAGE FORM

ABSTRACT Objective: To develop a stability indicating method development and validation of Clozapine by UV spectroscopic method in bulk and tablet dosage form and validate a simple, precise and cost-effective UV spectrophotometric method for the estimation of Clozapine according to the ICH Q2 (R1) guideline. Methods: standard Clozapine solution was scanned over UV-Visible range for its wavelength of maximum absorbance. Various calibration standards of Clozapine were prepared and absorbance was recorded at wavelength of maximum absorbance. Calibration curve of concentration vs. absorbance was plotted and linearity and range was calculated. Various analytical method validation parameters viz. accuracy, precision, LOD, LOQ, robustness and ruggedness were calculated. Results: The maximum wavelength of Clozapine was found to be 213 nm. The correlation coefficient over the concentration range of 10-50µg/mL was found to be 0.9997. Developed UV method was found to be precise during the intra-day and inter-day study and shows %RSD in the range of 0.94 & 1.10 respectively. The total percentage recovery of Clozapine was found to be 99.57 -100.73%. Developed method was found to be robust and rugged for the intended use. Clozapine content of marketed formulation was successfully calculated using developed UV method. Conclusion: A simple, precise and cost-effective UV spectrometry method for the estimation of Clozapine was developed and validated. This UV method can be efficiently used for the estimation of Clozapine in bulk as well as formulation. KEYWORDS: Clozapine, UV Spectroscopy, ICH guidelines