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A Validated Stability-Indicating RP-UPLC Method for Simultaneous Determination of Desloratadine and Sodium Benzoate in Oral Liquid Pharmaceutical Formulations.

Kumar N, Sangeetha D, Reddy PS, Prakash L - Sci Pharm (2011)

Bottom Line: To establish stability-indicating capability of the method, drug product was subjected to the stress conditions of acid, base, oxidative, hydrolytic, thermal and photolytic degradation.The degradation products were well resolved from desloratadine and sodium benzoate.The developed method was validated as per international ICH guidelines with respect to specificity, linearity, LOD, LOQ, accuracy, precision and robustness.

View Article: PubMed Central - PubMed

Affiliation: Analytical Research and Development, Integrated Product Development, Dr. Reddy's Laboratories Ltd., Bachupally, Hyderabad-500072, A.P., India.

ABSTRACT
A novel, sensitive and selective stability-indicating gradient reverse phase ultra performance liquid chromatographic method was developed and validated for the quantitative determination of desloratadine and sodium benzoate in pharmaceutical oral liquid formulation. The chromatographic separation was achieved on Acquity BEH C8 (100 mm × 2.1 mm) 1.7 μm column by using mobile phase containing a gradient mixture of solvent A (0.05 M KH(2)PO(4) and 0.07 M triethylamine, pH 3.0) and B (50:25:25 v/v/v mixture of acetonitrile, methanol and water) at flow rate of 0.4 mL/min. Column temperature was maintained at 40°C and detection was carried out at a wavelength of 272 nm. The described method shows excellent linearity over a range of 0.254 μg/mL to 76.194 μg/mL for desloratadine and 1.006 μg/mL to 301.67 μg/mL for sodium benzoate. The correlation coefficient for desloratadine and sodium benzoate was more than 0.999. To establish stability-indicating capability of the method, drug product was subjected to the stress conditions of acid, base, oxidative, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from desloratadine and sodium benzoate. The developed method was validated as per international ICH guidelines with respect to specificity, linearity, LOD, LOQ, accuracy, precision and robustness.

No MeSH data available.


Related in: MedlinePlus

Typical chromatogram of base degraded drug product
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f4-scipharm.2012.80.153: Typical chromatogram of base degraded drug product

Mentions: Base hydrolysis was carried out in 0.1 N NaOH at 50°C for 20 hr, but degradation of desloratadine was found to be less than 2% and sodium benzoate found stable. To increase the degradation, drug product was subjected to base hydrolysis in 1 N NaOH at 60°C for 20 hr. Fig 4 shows that the major degradation peaks found at RRT 1.12 and 1.39 with respect to desloratadine. All the major and minor degradation products were well separated from desloratadine and sodium benzoate peaks. The peak purity was checked for both analytes and the results are summarized in Table 2.


A Validated Stability-Indicating RP-UPLC Method for Simultaneous Determination of Desloratadine and Sodium Benzoate in Oral Liquid Pharmaceutical Formulations.

Kumar N, Sangeetha D, Reddy PS, Prakash L - Sci Pharm (2011)

Typical chromatogram of base degraded drug product
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3293360&req=5

f4-scipharm.2012.80.153: Typical chromatogram of base degraded drug product
Mentions: Base hydrolysis was carried out in 0.1 N NaOH at 50°C for 20 hr, but degradation of desloratadine was found to be less than 2% and sodium benzoate found stable. To increase the degradation, drug product was subjected to base hydrolysis in 1 N NaOH at 60°C for 20 hr. Fig 4 shows that the major degradation peaks found at RRT 1.12 and 1.39 with respect to desloratadine. All the major and minor degradation products were well separated from desloratadine and sodium benzoate peaks. The peak purity was checked for both analytes and the results are summarized in Table 2.

Bottom Line: To establish stability-indicating capability of the method, drug product was subjected to the stress conditions of acid, base, oxidative, hydrolytic, thermal and photolytic degradation.The degradation products were well resolved from desloratadine and sodium benzoate.The developed method was validated as per international ICH guidelines with respect to specificity, linearity, LOD, LOQ, accuracy, precision and robustness.

View Article: PubMed Central - PubMed

Affiliation: Analytical Research and Development, Integrated Product Development, Dr. Reddy's Laboratories Ltd., Bachupally, Hyderabad-500072, A.P., India.

ABSTRACT
A novel, sensitive and selective stability-indicating gradient reverse phase ultra performance liquid chromatographic method was developed and validated for the quantitative determination of desloratadine and sodium benzoate in pharmaceutical oral liquid formulation. The chromatographic separation was achieved on Acquity BEH C8 (100 mm × 2.1 mm) 1.7 μm column by using mobile phase containing a gradient mixture of solvent A (0.05 M KH(2)PO(4) and 0.07 M triethylamine, pH 3.0) and B (50:25:25 v/v/v mixture of acetonitrile, methanol and water) at flow rate of 0.4 mL/min. Column temperature was maintained at 40°C and detection was carried out at a wavelength of 272 nm. The described method shows excellent linearity over a range of 0.254 μg/mL to 76.194 μg/mL for desloratadine and 1.006 μg/mL to 301.67 μg/mL for sodium benzoate. The correlation coefficient for desloratadine and sodium benzoate was more than 0.999. To establish stability-indicating capability of the method, drug product was subjected to the stress conditions of acid, base, oxidative, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from desloratadine and sodium benzoate. The developed method was validated as per international ICH guidelines with respect to specificity, linearity, LOD, LOQ, accuracy, precision and robustness.

No MeSH data available.


Related in: MedlinePlus