Research Journal of Pharmacy and Technology

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Stability Indicating Rp-hplc Method for Simultaneous Estimation of Lamivudine, Stavudine and Nevirapine in Pure and Tablet Form


Affiliations
1 Department of Pharmaceutical Analysis and Quality Assurance, Institute of Pharmacy and Technology, Salipur, Cuttack, Orissa - 754202., India
     

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A new, simple, accurate, precise, reproducible, economical RP-HPLC method was developed for the simultaneous estimation of Lamivudine, Stavudine and Nevirapine in pure and pharmaceutical dosage form. A Phenomenex Gemini C6 Phenyl column (250mm × 4.6mm, 5μ) forms the stationary phase in isocratic mode, with the mobile phase consisting of 0.02 M Ammonium dihydrogen phosphate buffer having pH 2.5, adjusted with formic acid (98%). Buffer and methanol were used in the ratio of (50:50) to obtain well-resolved peaks of Lamivudine, Stavudine and Nevirapine from the combined dosage form. The flow rate and run time were set at 1 ml/min and 30 minutes respectively. The effluent was monitored at 264nm. The retention times for Lamivudine, Stavudine and Nevirapine were 2.837, 3.590, and 8.037 min respectively. The linearity for lamivudine, Stavudine and Nevirapine were in the range of 12-84, 24-160 and 16-112μg/ml respectively. The method was validated as per ICH guidelines Q 2B.

Keywords

RP-HPLC, Lamivudine, Stavudine, Nevirapine, Validation.
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  • Stability Indicating Rp-hplc Method for Simultaneous Estimation of Lamivudine, Stavudine and Nevirapine in Pure and Tablet Form

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Authors

S. K. Patro
Department of Pharmaceutical Analysis and Quality Assurance, Institute of Pharmacy and Technology, Salipur, Cuttack, Orissa - 754202., India
A. K. Prusty
Department of Pharmaceutical Analysis and Quality Assurance, Institute of Pharmacy and Technology, Salipur, Cuttack, Orissa - 754202., India

Abstract


A new, simple, accurate, precise, reproducible, economical RP-HPLC method was developed for the simultaneous estimation of Lamivudine, Stavudine and Nevirapine in pure and pharmaceutical dosage form. A Phenomenex Gemini C6 Phenyl column (250mm × 4.6mm, 5μ) forms the stationary phase in isocratic mode, with the mobile phase consisting of 0.02 M Ammonium dihydrogen phosphate buffer having pH 2.5, adjusted with formic acid (98%). Buffer and methanol were used in the ratio of (50:50) to obtain well-resolved peaks of Lamivudine, Stavudine and Nevirapine from the combined dosage form. The flow rate and run time were set at 1 ml/min and 30 minutes respectively. The effluent was monitored at 264nm. The retention times for Lamivudine, Stavudine and Nevirapine were 2.837, 3.590, and 8.037 min respectively. The linearity for lamivudine, Stavudine and Nevirapine were in the range of 12-84, 24-160 and 16-112μg/ml respectively. The method was validated as per ICH guidelines Q 2B.

Keywords


RP-HPLC, Lamivudine, Stavudine, Nevirapine, Validation.

References