1. Development and validation of a normal-phase HPTLC method for the simultaneous analysis of lamivudine, stavudine and nevirapine in fixed-dose combination tablets.
- Author
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Shewiyo DH, Kaale E, Ugullum C, Sigonda MN, Risha PG, Dejaegher B, Smeyers-Verbeke J, and Vander Heyden Y
- Subjects
- Anti-HIV Agents chemistry, Calibration, Chromatography, Thin Layer, Densitometry, Drug Combinations, Humans, Lamivudine chemistry, Nevirapine chemistry, Reproducibility of Results, Sensitivity and Specificity, Stavudine chemistry, Tablets analysis, Anti-HIV Agents analysis, Lamivudine analysis, Nevirapine analysis, Stavudine analysis
- Abstract
This paper presents the development and validation of an improved method for the simultaneous analysis of lamivudine (LVD), stavudine (STV) and nevirapine (NVP) using high-performance thin-layer chromatography (HPTLC) with densitometric detection. Separation was performed on silica gel 60F(254) plates. The mobile phase is comprised of ethylacetate, methanol, toluene and concentrated ammonia (38.7:19.4:38.7:3.2, v:v:v:v). Detection wavelength was 254 nm. The R(f) values were 0.24±0.03, 0.38±0.04 and 0.69±0.04 (n=8) for LVD, STV and NVP, respectively. An F-test indicated that calibration graphs were adequately linear at the evaluated concentration ranges. The pooled %RSD for repeatability of the percentage amount recovered for LVD, STV and NVP were found to be 0.62, 0.54, and 0.79, and the pooled %RSD for time-different intermediate precision were 1.66, 1.27 and 1.21. The percentage recoveries for the trueness were 99.2%±1.5 for LVD, 98.6%±1.5 for STV and 99.3%±1.7 for NVP (n=3). Most factors evaluated in the robustness test were found to have an insignificant effect on the selected responses at 95% confidence level. This method was successfully used to analyze fixed-dose tablets samples of LVD, STV and NVP., (Copyright © 2010 Elsevier B.V. All rights reserved.)
- Published
- 2011
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