Stability-Indicating HPLC Method for the Determination of Mometasone Furoate, Oxymetazoline, Phenyl Ethanol and Benzalkonium Chloride in Nasal Spray Solution

Shaikh, Kabeer A.; Patil, Ashish Tanaji

doi:10.7726/jtafd.2013.1002

Cited by 18 publications

(13 citation statements)

References 10 publications

(6 reference statements)

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“…Moreover, it acts locally in the lung as a bronchodilator [4]. The literature survey reveals that several analytical methods have been published for the estimation of MOM alone and in combination with other drugs like fusidic acid [5], oxymetazoline [6] terbinafine HCl, nadifloxacin [7], eberconazole nitrate [8], miconazole, hydrocortisone [9], ketoconazole [10], salicylic acid [12] etc. Some of these methods include HPLC, GC, supercritical fluid chromatography and UV spectrophotometry.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Estimation of Mometasone Furoate and Formoterol Fumarate by HPLC Method in Rotacaps

Zanwar

Sen

et al. 2018

Int J Pharm Pharm Sci

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Objective: To develop and validate a simple and sensitive RP-HPLC method for the simultaneous determination of mometasone furoate (MOM) and formoterol fumarate (FOR) in pharmaceutical dosage forms. Methods: In RP-HPLC method, chromatographic separation was achieved using a mixture of a solvent system consisting of methanol–water (pH 3.5) in the ratio of 85:15 % v/v at a flow rate of 1 ml/min and detection was carried out at 225 nm. Results: The run time for the simultaneous estimation of drugs for the proposed method was 10 min as drugs eluted at 5.217 min (MOM) and 8.650 min (FOR). The linearity was found in the range of 33.33-299.97 μg/ml and 1-9 μg/ml for MOM and FOR, respectively. The values of limit of detection and limit of quantification were 3.634, 0.266 µg/ml and 11.014, 0.807 µg/ml, which indicates the sensitivity of the method for the estimation of MOM and FOR, respectively. The results of recovery studies for both the drugs were within the range i.e. 98.87-101.48 % which indicates the accuracy of the method. Relative standard deviation obtained from repeatability and reproducibility studies were less than 2% indicates the precision of the method. The proposed method was validated according to ICH guidelines. Conclusion: The proposed RP-HPLC method was found to be sensitive and precise because of the low LOD, LOQ and % RSD values (<2). The proposed work does not require acetonitrile and ion pairing reagent as compared to the reported methods. Therefore, method can be used preferably for routine analysis due to its simplicity and economic advantages.

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Section: Introductionmentioning

confidence: 99%

Simultaneous Estimation of Mometasone Furoate and Formoterol Fumarate by HPLC Method in Rotacaps

Zanwar

Sen

et al. 2018

Int J Pharm Pharm Sci

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“…A detailed literature survey for methylparaben, mometasone furoate and eberconazole nitrate revealed that determination of individual compound or combination with other drugs have been reported by HPLC [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16] , LCMS [17][18] , electrophoresis 19 and spectrophotometric method 20 .…”

mentioning

confidence: 99%

Development and Validation of a Novel Stability Indicating RP-UPLC Method for Simultaneous Estimation of Methylparaben, Mometasone Furoate and Eberconazole Nitrate in Combined Topical Pharmaceutical Dosage Form

2013

Chem Sci Trans

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A novel, rapid, simple, stability indicating RP-UPLC method development and validation for simultaneous estimation of methylparaben (MP), mometasone furoate (MF) and eberconazole nitrate (EN) in topical pharmaceutical dosage form. Isocratic chromatographic separation was achieved on Acquity BEH C18, column using mobile phase consist of buffer (0.1%v/v triethylamine in water pH 6.0 by Glacial acetic acid), acetonitrile in the ratio (40:60, v/v) at flow rate 0.4 mL/min and detection was monitored at 235 nm by using photo-diode array detector. The method shows excellent linearity over the range of 2.75-152.7 µg/mL, 4.45-60.7 µg/mL and 9.10-606.6 µg/mL for methylparaben, mometasone furoate and eberconazole nitrate respectively. Recovery was found for all the components to be in the range of 98.4-101.7%. Stability indicating capability of developed method was established by analysing forced degradation samples in which spectral purity of methylparaben, mometasone furoate and eberconazole nitrate along with separation of degradation products from analytes peak. The proposed method was successfully applied for the quantitative estimation of MP, MF and EN in cream sample.

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“…A number of analytical methods have been reported for the estimation of BKC in various products including ophthalmic preparations [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23]. However, there was no method available for estimation of BKC in azelastine hydrochloride ophthalmic formulations.…”

Section: Introductionmentioning

confidence: 99%

A Study on Forced Degradation and Validation of Stability Indicating Rp-HPLC Method for Determination of Benzalkonium Chloride in Azelastine Hydrochoride Pharmaceutical Ophthalmic Formulation

Gupta

Chaturvedi

2017

Asian J Pharm Clin Res

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Objective: This study was designed to conduct forced degradation and validation studies for determination the benzalkonium chloride (BKC) as major homologues form in azelastine hydrochloride pharmaceutical ophthalmic formulation by a novel stability indicating reverse phase high-performance liquid chromatographic method (RP-HPLC).Methods: Forced degradation study and validation were carried out with a analytical approach of reverse phase chromatographic analysis with C18, cosmosil (250mm x 4.6mm i.d. x 5µm) column using mobile phase consisting acetonitrile -buffer of pH 5.0 with 5N NaOH (45:55 %v/v) at a flow rate of 1.5 ml per minute. Column temperature was maintained at 25°C and detection wavelength was 210nm.By using these chromatographic conditions of method, two major homologues of benzalkonium chloride were separated without any interference of drug components and exciepients.Results: Forced degradation studies were carried out as per ICH guidelines and established a stability indicating property of a method .The method was found linear in concentration range 40µg/ml to 60µg/ml (50µg/ml±20%), correlation coefficient was found 0.999. The recovery was found to be 99.2%, 100.7% and 101.4% at ±30% of target concentration. The %RSD for method precision and intermediate precision were found 0.28% and 0.30 % respectively. The method was found specific, selective, precise, accurate, linear, robust and stability indicating for quantification benzalkonium chloride in azelastine pharmaceutical ophthalmic formulation. Conclusion:The method has been found successful for determination of BKC pharmaceutical formulation and validated for all the parameters of validation and found within the acceptance criteria as per ICH guideline Q2R1.

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Stability-Indicating HPLC Method for the Determination of Mometasone Furoate, Oxymetazoline, Phenyl Ethanol and Benzalkonium Chloride in Nasal Spray Solution

Cited by 18 publications

References 10 publications

Simultaneous Estimation of Mometasone Furoate and Formoterol Fumarate by HPLC Method in Rotacaps

Simultaneous Estimation of Mometasone Furoate and Formoterol Fumarate by HPLC Method in Rotacaps

Development and Validation of a Novel Stability Indicating RP-UPLC Method for Simultaneous Estimation of Methylparaben, Mometasone Furoate and Eberconazole Nitrate in Combined Topical Pharmaceutical Dosage Form

A Study on Forced Degradation and Validation of Stability Indicating Rp-HPLC Method for Determination of Benzalkonium Chloride in Azelastine Hydrochoride Pharmaceutical Ophthalmic Formulation

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