A study of method development and validation for estimation of Azelastine hydrochloride in nasal spray formulations by RP-HPLC method

Gill, Charansingh H.; Kulkarni, Pankaj N.; Nipate, Amol S.; Jadhav, Chetan K.; Chate, Asha V.; Dodake-Supekar, Alaknanda M.

doi:10.22270/jddt.v8i6-s.2222

Cited by 3 publications

(1 citation statement)

References 2 publications

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“…Anti-inflammatory medicines help to stop this process and prevent asthma attacks. There are three main types of drugs available for anti-inflammatory effects are corticosteroids, decongestants and antihistamines [1,2].…”

Section: Introductionmentioning

confidence: 99%

The QUALITY BY DESIGN APPROACH FOR SIMULTANEOUS DETERMINATION OF FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

et al. 2020

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Objective: To develop and validate a novel and simple reverse phase Ultra Performance Liquid Chromatography (UPLC) method for simultaneous determination of Fluticasone Propionate and Salmeterol Xinafoate from pharmaceutical finished product, applying Quality by design (QbD) approach. Methods: The proposed analytical method developed and validated in a linear gradient condition at a flow rate of 0.40 ml/min over Waters ACQUITY BEH Shield RP 18, 2.1*100 mm, 1.7 µm column by maintaining column oven temperature at 30 °C and Sample cooler temperature at 15 °C. Chromatograms monitored and recorded at 215 nm. Results: The proposed method has been validated as per International Conference on Harmonization (ICH) guidelines with respect to system suitability, specificity, precision, linearity, accuracy, range, solution stability and robustness. This method is qualified in all parameters in case of system suitability and specificity; precision observed within the limit of 2.0%, the excellent linear response observed with correlation coefficient (R2) for Salmeterol 0.99999 and Fluticasone Propionate 0.99999, for Accuracy within the limit of 98% to 102%. Conclusion: A selective, suitable and accurate reverse phase UPLC method for simultaneous Determination of Fluticasone Propionate and Salmeterol Xinafoate in the pharmaceutical finished product has been developed and validated successfully.

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Section: Introductionmentioning

confidence: 99%

The QUALITY BY DESIGN APPROACH FOR SIMULTANEOUS DETERMINATION OF FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

et al. 2020

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Development and Validation of Stability-Indicating Impurity Profiling Method for Azelastine Hydrochloride and Fluticasone Propionate in Nasal Spray Product Using HPLC with a UV/PDA Detector

Musmade¹,

Korhale²,

Sable³

et al. 2023

Journal of AOAC International

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Background This Azelastine HCl (AZ) and Fluticasone propionate (FL) nasal spray drug product is commonly used in the treatment of allergic rhinitis worldwide. The impurity profiling of this product is not reported till date. Objective The present study is aimed to develop and validate a novel stability indicating analytical method for the estimation of impurities from Azelastine Hydrochloride and Fluticasone Propionate nasal spray drug product. Methods A mixture of octane sulfonic acid sodium salt and trifluroacetic acid is used as a mobile phase A. Acetonitrile is used as a mobile phase B. Good separation was achieved on Baker bond phenyl hexyl, 250 x 4.6, 5 µm column at 1 mL/min flow rate in gradient elution mode. The chromatograms were monitored at 239 nm. Results The limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.006 and 0.019 µg/mL for AZ and 0.010 and 0.030 µg/mL for FL, respectively. The correlation coefficient for all the known impurities and principle analytes was observed 0.999 from LOQ level to 150% of standard concentration. The recovery for all the known impurities was found to be between 90 to 110%. During stress study, 15% degradation was observed in basic condition and 8.7% in acidic condition. No significant degradation was observed in thermal and oxidative conditions. Conclusion The impurity profiling method for AZ and FL combination nasal spray product was successfully developed, validated and demonstrated to be accurate, precise, specific, robust and stability indicating. The method can be routinely used for the impurity testing of commercial batches in quality control laboratories in the pharmaceutical industry. Highlights No impurity study has been reported for this combination product till date.

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Stability Indicating RP-HPLC Method Development and Validation for Dexamethasone

et al. 2020

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A new, simple, reliable and reproducible stability indicating RP-HPLC assay method has been developed for quantitative analysis of dexamethasone from dexamethasone tablets. This developed method has been validated according to ICH guideline with respect to system suitability, specificity, precision, linearity, accuracy and robustness. An isocratic condition of mobile phase water (0.1% orthophosphoric acid):acetonitrile in a ratio of 60:40, v/v at a flow rate of 1.0 mL/minute over RP 2.5 Fortis C18, 100 × 4.6 mm, 2.5 μm, column was at 27 ºC maintained. This method is specific and showed excellent linear response with correlation coefficient (R2) values of 0.999. In forced degradation, the proposed method has been investigated with different stress conditions as hydrolytic, oxidative, thermal and humid as recommended by ICH guidelines. An accurate and reliable reversed-phase HPLC method for the analysis of dexamethasone in dexamethasone tablets was developed and validated successfully.

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A study of method development and validation for estimation of Azelastine hydrochloride in nasal spray formulations by RP-HPLC method

Cited by 3 publications

References 2 publications

The QUALITY BY DESIGN APPROACH FOR SIMULTANEOUS DETERMINATION OF FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

The QUALITY BY DESIGN APPROACH FOR SIMULTANEOUS DETERMINATION OF FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

Development and Validation of Stability-Indicating Impurity Profiling Method for Azelastine Hydrochloride and Fluticasone Propionate in Nasal Spray Product Using HPLC with a UV/PDA Detector

Stability Indicating RP-HPLC Method Development and Validation for Dexamethasone

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