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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

Chemical structures of desloratadine and sodium benzoate.
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f1-scipharm.2012.80.153: Chemical structures of desloratadine and sodium benzoate.

Mentions: Desloratadine, 8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta-[1,2-b]pyridine (Fig. 1), is a peripheral histamine H1-receptor anatagonist commonly used to treat allergy symptoms such as nasal and nonnasal symptoms of seasonal allergic rhinits. Desloratadine is available as 5 mg tablets and 0.5 mg/mL syrup [1, 2]. Compared to tablet and capsule, liquid formulations favour a most rapid absorption of active substance. Liquid preparations are particularly susceptible to mocrobial growth because of the nature of their ingradtient. Such preparations require the presence of preservatives and antimicrobial agents to prevent chemical alteration and degradation of drug substance.


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)

Chemical structures of desloratadine and sodium benzoate.
© Copyright Policy
Related In: Results  -  Collection

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

f1-scipharm.2012.80.153: Chemical structures of desloratadine and sodium benzoate.
Mentions: Desloratadine, 8-chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta-[1,2-b]pyridine (Fig. 1), is a peripheral histamine H1-receptor anatagonist commonly used to treat allergy symptoms such as nasal and nonnasal symptoms of seasonal allergic rhinits. Desloratadine is available as 5 mg tablets and 0.5 mg/mL syrup [1, 2]. Compared to tablet and capsule, liquid formulations favour a most rapid absorption of active substance. Liquid preparations are particularly susceptible to mocrobial growth because of the nature of their ingradtient. Such preparations require the presence of preservatives and antimicrobial agents to prevent chemical alteration and degradation of drug substance.

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