Monday , 26 February 2024

Analytical Method Development and Validation for the Simultaneous Estimation of Olanzapine and Samidorphan in its bulk and Pharmaceutical Dosage forms

Vallabhu Mohan Teja1*, Gope Edward Raju2, Kandregula Uma Maheswari3, Doonaboyina Raghava4, Kavala Nageswara Rao5
 Department of Pharmaceutical Analysis, K.G.R.L College of Pharmacy, Bhimavaram-534201, A.P, India

A b s t r a c t
A new method was established for simultaneous estimation of Olanzapine and Samidorphan by RP-HPLC method.  The chromatographic conditions were successfully developed for these parathion of Olanzapine and Samidorphan by using AgilentC185µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer ph 4.0: ACN  (30:70%v/v), detection wavelength was 254nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-softwareversion-2. The retention times were found to be 3.503mins and 2.577mins. The % purity of Olanzapine and Samidorphan was found to be 100.3 % and 101.1 % respectively. The system suitability parameters for Olanzapine and Samidorphan such as theoretical plates and tailing factor were found to be 1.3, 5824.4 and 1.2, 2936.0 the resolution was found to be 9.4. The analytical method was validated according to ICH guidelines (ICH,Q2(R1)). The linearity study for Olanzapine and Samidorphan was found  in  concentration  range   of  20μg-100μg  and  20μg-100μg   and correlation coefficient(r2) was found to be 0.999 and 0.999, % mean recovery was found to be 102.5 % and 101.0%, % RSD for repeatability was0.6 and 0.5, %RSD for intermediate precision was 0.7 and 0.6 respectively. The precision study was precise, robust, and repeatable. LOD value was 3.1 and 3.02, and LOQ value was 10.1 and 10 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Olanzapine and Samidorphan in API and Pharmaceutical dosage form.

Keywords: AgilentC18, Olanzapine and Samidorphan, RP-HPLC

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