Saturday , 22 June 2024

RP-HPLC Method Development and Validation for the Estimation of Olanzapine in bulk drug and tablet dosage form

Gobalakrishnan P*1, Munisekhar V, Hemanth Kumar V
1Department of Pharmaceutical Analysis, Vagdevi College of Pharmacy and Research Centre, Nellore, Andhra Pradesh, India.

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The methods developed for the determination of Olanzapine are simple, selective and offer the advantages of high sensitivity without the need for extraction.. A new method was developed for Stability Indicating Assay Method for the Determination of Olanzapine in Tablet Dosage by using RP-HPLC method. The optimized chromatographic conditions were Capcell pak C-18, (250×4.6mm), 5µm colum, flow rate was 1ml/min, Acetonitrile, Methanol: water (50:50%V/V) and the detection wavelength was 251nm. The linearity of the method was demonstrated over the concentration range of 2-12µg/ml. correlation Coefficient should be less than 0.999, detection Limit was 0.635 µg / ml, quantification Limit was 1.93 µg / ml. The correlation coefficient (R2) for Sultiam peak was found to be 1.000. The analytical method was validated according to ICH, Q2(R1). Hence the suggested RP-HPLC method can be used for routine analysis of sultiam in API and tablet dosage form. The proposed reagents are easily available and cost-effective, and these methods do not involve any stringent reaction conditions and non-interference from associated substances in the dosage forms. The methods developed have been utilized to determine Olanzapine in pure as well as in pharmaceutical samples
Keywords: Olanzapine, HPLC, correlation coefficient, ICH

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