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METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF NEVIRAPINE AND LAMIVUDINE IN HUMAN PLASMA BY LC-MS/MS

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Abstract (2. Language): 
The present work deals with a simple and accurate liquid chromatography mass spectrometry method for the simultaneous estimation of Nevirapine and Lamivudine from their combination drug product with carbamazepine as internal standard. The proposed LC-MS/MS method utilizes HyPURITY ADVANCE 4.6x50 mm, 5 microm (make thermo) column, at ambient temperature, optimum mobile phase consists of methanol: 5M ammonium acetate buffer (85; 15v/v) and flow rate monitored at 0.800 ml/min. the linearity of the proposed method was investigated in the range of 25.45ng/ml to 4990.23 mg/ml concentrations for Nevirapine and 15.30 mg/ml to 2999.63 mg/ml concentrations for Lamivudine1. The mean recoveries were 93.58% and 91.73% for Nevirapine and Lamivudine, respectively. The proposed method was validated for precision, accuracy, linearity, range, robustness and ruggedness. All validation parameters were within the acceptable range. The developed method was successfully applied to estimate the amount of Nevirapine and Lamivudine in combined dosage forms.
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