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Stress degradation studies on varenicline tartrate and development of a validated stability-indicating HPLC method.

Pujeri SS, Khader AM, Seetharamappa J - Sci Pharm (2011)

Bottom Line: The method was found to be simple, specific, precise and accurate.The peaks of degradation products did not interfere with that of pure VRT.The results of analysis were subjected to statistical analysis.

View Article: PubMed Central - PubMed

Affiliation: Department of Chemistry, Mangalore University, Mangalagangotri, India.

ABSTRACT
A simple, rapid and stability-indicating reversed-phase liquid chromatographic method was developed for the assay of varenicline tartrate (VRT) in the presence of its degradation products generated from forced decomposition studies. The HPLC separation was achieved on a C18 Inertsil column (250 mm × 4.6 mm i.d. particle size is 5 μm) employing a mobile phase consisting of ammonium acetate buffer containing trifluoroacetic acid (0.02M; pH 4) and acetonitrile in gradient program mode with a flow rate of 1.0 mL min(-1). The UV detector was operated at 237 nm while column temperature was maintained at 40 °C. The developed method was validated as per ICH guidelines with respect to specificity, linearity, precision, accuracy, robustness and limit of quantification. The method was found to be simple, specific, precise and accurate. Selectivity of the proposed method was validated by subjecting the stock solution of VRT to acidic, basic, photolysis, oxidative and thermal degradation. The calibration curve was found to be linear in the concentration range of 0.1-192 μg mL(-1) (R(2) = 0.9994). The peaks of degradation products did not interfere with that of pure VRT. The utility of the developed method was examined by analyzing the tablets containing VRT. The results of analysis were subjected to statistical analysis.

No MeSH data available.


Related in: MedlinePlus

Typical chromatograms of VRT exposed to 10 % hydrogen peroxide (a), 80°C (b), 1 M hydrochloric acid (c), 1 M sodium hydroxide (d) and UV light (e)
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f3-scipharm.2012.80.115: Typical chromatograms of VRT exposed to 10 % hydrogen peroxide (a), 80°C (b), 1 M hydrochloric acid (c), 1 M sodium hydroxide (d) and UV light (e)

Mentions: Stress studies on VRT were carried out under oxidation, thermal stress, photolysis, acid and base hydrolysis conditions. It was found that the degradation was not observed in VRT sample when it was subjected to oxidation, thermal stress, acid and base hydrolysis (Figs. 3a, 3b, 3c and 3d). However, degradation products were found in photolysis stress conditions (Fig 3e).


Stress degradation studies on varenicline tartrate and development of a validated stability-indicating HPLC method.

Pujeri SS, Khader AM, Seetharamappa J - Sci Pharm (2011)

Typical chromatograms of VRT exposed to 10 % hydrogen peroxide (a), 80°C (b), 1 M hydrochloric acid (c), 1 M sodium hydroxide (d) and UV light (e)
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3293356&req=5

f3-scipharm.2012.80.115: Typical chromatograms of VRT exposed to 10 % hydrogen peroxide (a), 80°C (b), 1 M hydrochloric acid (c), 1 M sodium hydroxide (d) and UV light (e)
Mentions: Stress studies on VRT were carried out under oxidation, thermal stress, photolysis, acid and base hydrolysis conditions. It was found that the degradation was not observed in VRT sample when it was subjected to oxidation, thermal stress, acid and base hydrolysis (Figs. 3a, 3b, 3c and 3d). However, degradation products were found in photolysis stress conditions (Fig 3e).

Bottom Line: The method was found to be simple, specific, precise and accurate.The peaks of degradation products did not interfere with that of pure VRT.The results of analysis were subjected to statistical analysis.

View Article: PubMed Central - PubMed

Affiliation: Department of Chemistry, Mangalore University, Mangalagangotri, India.

ABSTRACT
A simple, rapid and stability-indicating reversed-phase liquid chromatographic method was developed for the assay of varenicline tartrate (VRT) in the presence of its degradation products generated from forced decomposition studies. The HPLC separation was achieved on a C18 Inertsil column (250 mm × 4.6 mm i.d. particle size is 5 μm) employing a mobile phase consisting of ammonium acetate buffer containing trifluoroacetic acid (0.02M; pH 4) and acetonitrile in gradient program mode with a flow rate of 1.0 mL min(-1). The UV detector was operated at 237 nm while column temperature was maintained at 40 °C. The developed method was validated as per ICH guidelines with respect to specificity, linearity, precision, accuracy, robustness and limit of quantification. The method was found to be simple, specific, precise and accurate. Selectivity of the proposed method was validated by subjecting the stock solution of VRT to acidic, basic, photolysis, oxidative and thermal degradation. The calibration curve was found to be linear in the concentration range of 0.1-192 μg mL(-1) (R(2) = 0.9994). The peaks of degradation products did not interfere with that of pure VRT. The utility of the developed method was examined by analyzing the tablets containing VRT. The results of analysis were subjected to statistical analysis.

No MeSH data available.


Related in: MedlinePlus