A validated stability-indicating UPLC method for desloratadine and its impurities in pharmaceutical dosage forms

Rao, Dantu Durga; Satyanarayana, N.; Reddy, A. Malleswara; Sait, Shakil S.; Chakole, Dinesh; Mukkanti, K.

doi:10.1016/j.jpba.2009.09.016

Cited by 29 publications

(9 citation statements)

References 9 publications

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“…The research conditions force the drug compounds to degrade under tremendous conditions such as acid and base hydrolysis, peroxide oxidation, photo-oxidation, and thermal stability to identify the resultant degradation products. Stability indicating method using UHPLC-MS/MS is included in Table 4 [147][148][149][150][151][152][153] Impurity profile of drug using UHPLC/MS/MS For the medicine development and formulation process, profiling, detection, and evaluation of drug substances and their contamination in crude materials and finishing yield testing is an essential part which is summarized in Table 5 [3] [154][155][156][157][158][159][160][161][162][163].…”

Section: Stability-indicating Methods Using Uhplc-ms/msmentioning

confidence: 99%

Ultra-high performance liquid chromatography-MS/MS (UHPLC-MS/MS) in practice: analysis of drugs and pharmaceutical formulations

et al. 2019

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Background: UHPLC-MS/MS is connected in various research facilities for the qualitative and quantitative investigation of a pharmaceutical substance, pharmaceutical items, and biological specimen. Main body: The commence review article is an endeavor to offer pervasive awareness around assorted aspects and details about the UHPLC-MS/MS and related techniques with the aim on practice to an estimation of medicinal active agents in the last 10 years. The article also focused on isolation, separation, and characterization of present impurity in drug and biological samples. Conclusion: Review article compiles a general overview of medicinally important drugs and their analysis with UHPLC-MS/MS. It gives fundamental thought regarding applications of UHPLC-MS/MS for the study on safety limit. The summary of developed UHPLC-MS/MS methods gives a contribution to the future trend and limitations in this area of research.

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Section: Stability-indicating Methods Using Uhplc-ms/msmentioning

confidence: 99%

Ultra-high performance liquid chromatography-MS/MS (UHPLC-MS/MS) in practice: analysis of drugs and pharmaceutical formulations

et al. 2019

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“…Regarding DSL, several methods have been derived for its determination, such as spectrophotometry (26,27), spectrofluorimetry (27), liquid chromatography (12)(13)(14)(15)(16)(17)(18)(19)(20)(27)(28)(29), gas chromatography (23) and capillary isotachophoresis (30).…”

Section: Introductionmentioning

confidence: 99%

Stability‐indicating micelle‐enhanced spectrofluorimetric method for determination of loratadine and desloratadine in dosage forms

et al. 2011

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A highly sensitive and simple spectrofluorimetric method was developed for the determination of loratadine (LRT) and desloratadine (DSL) in their pharmaceutical formulations. The proposed method is based on investigation of the fluorescence spectral behaviour of LRT and DSL in a sodium dodecyl sulphate (SDS) micellar system. In aqueous solution of acetate buffer of pH 4.5, the fluorescence intensities of both LRT and DSL were greatly enhanced (240%) in the presence of SDS. The fluorescence intensity was measured at 438 nm after excitation at 290 nm for both drugs. The fluorescence-concentration plots were rectilinear over the range 0.05-2.0 µg/mL for both LRT and DSL, with lower detection limits of 5.13 × 10(-3) and 6.35 × 10(-3) µg/mL for LRT and DSL, respectively. The method was successfully applied to the analysis of the two drugs in their commercial tablets, capsules and syrups, and the results were in good agreement with those obtained with the official or comparison methods. The proposed method is specific for the determination of LRT in the presence of other co-formulated drugs, such as pseudoephedrine. The application of the proposed method was extended to stability studies of LRT and DSL after exposure to different forced degradation conditions, such as acidic, alkaline and oxidative conditions, according to ICH guidelines.

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“…Miconazole has a number of known impurities, which are close in structure to the main compound. The high‐performance liquid chromatography (HPLC) method for the determination of the related substances is described in the European Pharmacopeia (Ph.Eur), a set of texts concerning the qualitative and quantitative composition of pharmaceutical preparations and the tests to be carried out on medicines, on the raw materials used in the production of pharmaceutical preparations, and on the intermediates of synthesis …”

Section: Introductionmentioning

confidence: 99%

Development of stability indicating HPLC method for the separation and validation of enantiomers of miconazole

et al. 2018

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A selective and sensitive stability indicting HPLC method was developed for the analysis of enantiomers of miconazole. For this purpose, six different polysaccharide-based chiral columns were evaluated. Optimization was performed using several polar organic and alcohol-hydrocarbon mobile phases. As a result of optimization studies, the analysis was carried out using Lux Cellulose-3, methanol as a mobile phase at a flow rate of 1 mL·min , and the detection wavelength was arranged to 230 nm. Developed method has been fully validated according to International Council on Harmonization guidelines. Method was found linear in the concentration range of 1 to 200 μg·mL . Coefficient of determination (R ) was calculated as 0.9996, intraday precision of the method was found with the RSD% of 0.56, and the recovery of the method was calculated close to 100%. Furthermore, some other validation parameters like specificity, selectivity, LOD, and LOQ were also investigated. Stability indicating capability of this method was shown by forced degradation studies, and the run time for each analysis was less than 6 minutes. As a result, simple, fast, reliable HPLC method was developed for the separation and determination of the enantiomers of miconazole. Applicability of the developed method was shown with the application of marketed pharmaceutical preparations.

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A validated stability-indicating UPLC method for desloratadine and its impurities in pharmaceutical dosage forms

Cited by 29 publications

References 9 publications

Ultra-high performance liquid chromatography-MS/MS (UHPLC-MS/MS) in practice: analysis of drugs and pharmaceutical formulations

Ultra-high performance liquid chromatography-MS/MS (UHPLC-MS/MS) in practice: analysis of drugs and pharmaceutical formulations

Stability‐indicating micelle‐enhanced spectrofluorimetric method for determination of loratadine and desloratadine in dosage forms

Development of stability indicating HPLC method for the separation and validation of enantiomers of miconazole

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