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Development and Validation of Liquid Chromatographic Method for Estimation of Naringin in Nanoformulation.

Musmade KP, Trilok M, Dengale SJ, Bhat K, Reddy MS, Musmade PB, Udupa N - J Pharm (Cairo) (2014)

Bottom Line: UV detection was carried out at 282 nm.The intra- and interday precision studies showed good reproducibility with coefficients of variation (CV) less than 1.0%.The mean recovery of NAR was found to be 99.33 ± 0.16%.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal 576104, India.

ABSTRACT
A simple, precise, accurate, rapid, and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method with UV detection has been developed and validated for quantification of naringin (NAR) in novel pharmaceutical formulation. NAR is a polyphenolic flavonoid present in most of the citrus plants having variety of pharmacological activities. Method optimization was carried out by considering the various parameters such as effect of pH and column. The analyte was separated by employing a C18 (250.0 × 4.6 mm, 5 μm) column at ambient temperature in isocratic conditions using phosphate buffer pH 3.5: acetonitrile (75 : 25% v/v) as mobile phase pumped at a flow rate of 1.0 mL/min. UV detection was carried out at 282 nm. The developed method was validated according to ICH guidelines Q2(R1). The method was found to be precise and accurate on statistical evaluation with a linearity range of 0.1 to 20.0 μg/mL for NAR. The intra- and interday precision studies showed good reproducibility with coefficients of variation (CV) less than 1.0%. The mean recovery of NAR was found to be 99.33 ± 0.16%. The proposed method was found to be highly accurate, sensitive, and robust. The proposed liquid chromatographic method was successfully employed for the routine analysis of said compound in developed novel nanopharmaceuticals. The presence of excipients did not show any interference on the determination of NAR, indicating method specificity.

No MeSH data available.


Related in: MedlinePlus

Effect of column on capacity factor and theoretical plate on standard NAR.
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Related In: Results  -  Collection


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fig3: Effect of column on capacity factor and theoretical plate on standard NAR.

Mentions: There was no significant change in the retention time of the NAR in all the above columns. The GraceSmart RP C18 (250 × 4.6 mm, 5 μm) column showed good peak shape, less tailing, and acceptable retention time with better column efficiency compared to all other columns. Hence, in the present study GraceSmart RP C18 (250.0 × 4.6 mm, 5 μm) was selected as the column for the analysis. The effect of column on chromatographic factors mainly capacity factor and theoretical plates was represented in Figure 3. The highest capacity factor that is 1.8 with highest theoretical plates count was observed with GraceSmart RP C18 (250.0 × 4.6 mm, 5 μm). The results for system suitability parameters were tabulated in Table 4.


Development and Validation of Liquid Chromatographic Method for Estimation of Naringin in Nanoformulation.

Musmade KP, Trilok M, Dengale SJ, Bhat K, Reddy MS, Musmade PB, Udupa N - J Pharm (Cairo) (2014)

Effect of column on capacity factor and theoretical plate on standard NAR.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4590809&req=5

fig3: Effect of column on capacity factor and theoretical plate on standard NAR.
Mentions: There was no significant change in the retention time of the NAR in all the above columns. The GraceSmart RP C18 (250 × 4.6 mm, 5 μm) column showed good peak shape, less tailing, and acceptable retention time with better column efficiency compared to all other columns. Hence, in the present study GraceSmart RP C18 (250.0 × 4.6 mm, 5 μm) was selected as the column for the analysis. The effect of column on chromatographic factors mainly capacity factor and theoretical plates was represented in Figure 3. The highest capacity factor that is 1.8 with highest theoretical plates count was observed with GraceSmart RP C18 (250.0 × 4.6 mm, 5 μm). The results for system suitability parameters were tabulated in Table 4.

Bottom Line: UV detection was carried out at 282 nm.The intra- and interday precision studies showed good reproducibility with coefficients of variation (CV) less than 1.0%.The mean recovery of NAR was found to be 99.33 ± 0.16%.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal 576104, India.

ABSTRACT
A simple, precise, accurate, rapid, and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method with UV detection has been developed and validated for quantification of naringin (NAR) in novel pharmaceutical formulation. NAR is a polyphenolic flavonoid present in most of the citrus plants having variety of pharmacological activities. Method optimization was carried out by considering the various parameters such as effect of pH and column. The analyte was separated by employing a C18 (250.0 × 4.6 mm, 5 μm) column at ambient temperature in isocratic conditions using phosphate buffer pH 3.5: acetonitrile (75 : 25% v/v) as mobile phase pumped at a flow rate of 1.0 mL/min. UV detection was carried out at 282 nm. The developed method was validated according to ICH guidelines Q2(R1). The method was found to be precise and accurate on statistical evaluation with a linearity range of 0.1 to 20.0 μg/mL for NAR. The intra- and interday precision studies showed good reproducibility with coefficients of variation (CV) less than 1.0%. The mean recovery of NAR was found to be 99.33 ± 0.16%. The proposed method was found to be highly accurate, sensitive, and robust. The proposed liquid chromatographic method was successfully employed for the routine analysis of said compound in developed novel nanopharmaceuticals. The presence of excipients did not show any interference on the determination of NAR, indicating method specificity.

No MeSH data available.


Related in: MedlinePlus