SIMULTANEOUS ESTIMATION OF MOMETASONE FUROATE AND FORMOTEROL FUMARATE BY HPLC METHOD IN ROTACAPS

Aarti S. Zanwar; Dhanya B. Sen; Ashim Kumar Sen; A. K. Seth

doi:10.22159/ijpps.2019v11i2.24799

Authors

Aarti S. Zanwar Department of Pharmacy, Sumandeep Vidyapeeth University, Piparia, Waghodia, Vadodara 391760, Gujarat, India
Dhanya B. Sen Department of Pharmacy, Sumandeep Vidyapeeth University, Piparia, Waghodia, Vadodara-391760, Gujarat, India
Ashim Kumar Sen Department of Pharmacy, Sumandeep Vidyapeeth University, Piparia, Waghodia, Vadodara-391760, Gujarat, India
A. K. Seth Department of Pharmacy, Sumandeep Vidyapeeth University, Piparia, Waghodia, Vadodara-391760, Gujarat, India

DOI:

https://doi.org/10.22159/ijpps.2019v11i2.24799

Keywords:

RP- HPLC, Mometasone furoate, Formoterol fumarate, Analytical method

Abstract

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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References

Allen DB, Bielory L, Derendorf H, Dluhy R, Colice GL, Szefler SJ. Inhaled corticosteroids: past lessons and future issues. J Allergy Clin Immunol 2003;112:S1-40.

Kosoglou T, Hubbel J, Xuan F, Cutler DL, Meehan AG, Kantesaria B, et al. Comparison of the systemic bioavailability of mometasone furoate after oral inhalation from a mometasone furoate/formoterol fumarate metered-dose inhaler versus a mometasone furoate dry-powder inhaler in patients with chronic obstructive pulmonary disease. Int J Chronic Obstruct Pulm Dis 2013;8:107–16.

Nayak AS, Banov M, Corren J, Feinstein BK, Anthony Floreani, Friedman BF, et al. Once-daily mometasone furoate dry powder inhaler in the treatment of patients with persistent asthma. Ann Allergy Asthma Immunol 2000;84:417-24.

Akapo SO, Muhammad A. Validation of a RP-HPLC method for the assay of formoterol and its related substances in formoterol fumarate dehydrate. J Pharm Biomed Anal 2003;33:935-45.

Malik K, Kumar D, Tomar V, Kaskhedikar S, Soni L. A simple RP-HPLC method for the simultaneous quantitation of chlorocresol, mometasone furoate and fusidic acid in creams. Pharm Sinica 2011;2:77-84.

Shaikh KA, Patil AT. Stability-Indicating HPLC method for the determination of mometasone furoate, oxymetazoline, phenyl ethanol and benzalkonium chloride in nasal spray solution. J Trace Anal Food Drugs 2013;1:14-21.

Kulkarni A, Nanda RK, Ranjane MN, Ranjane PN. Simultaneous estimation of nadifloxacin and mometasone furoate in topical cream by HPTLC method. Der Pharma Chem 2010;2:25-30.

Sharma N, Rao SS, Vaghela B. Validated stability-indicating high-performance liquid chromatographic method for estimation of degradation behaviour of eberconazole nitrate and mometasone furoate in cream formulation. Indian J Pharm Sci 2013;75:76-82.

El‐Bagary RI, Elkady EF, Tammam MH, Elmaaty AA. Simultaneous determination of miconazole and hydrocortisone or mometasone using reversed phase liquid chromatography. Eur J Chem 2012;3:421‐5.

Roy C, Chakrabarty J. Stability-Indicating validated novel RP-HPLC method for simultaneous estimation of methylparaben, ketoconazole and mometasone furoate in topical pharmaceutical dosage formulation. ISRN Analytical Chemistry 2013;9. http://dx.doi.org/10.1155/2013/342794

El‐Bagary RI, Fouada MA, El-Shaalb MA, Tolba EH. Derivative, derivative of the ratio spectrophotometric and stability-indicating RP-HPLC methods for the determination of mometasone furoate and miconazole nitrate in cream. J Chem Pharm Res 2013;5:368-78.

Vanani DR, Desai SD, Patel KG, Shah PA. Application of ratio derivative spectrophotometry for simultaneous determination of mometasone furoate and salicylic acid in semisolid dosage form. Int J Anal Bioanal Chem 2013;3:67-71.

Campestrini J, Lecaillon JB, Godbillon J. Automated and sensitive method for the determination of formoterol in human plasma by high-performance liquid chromatography and electrochemical detection. J Chromatogr B 1997;704:221-9.

Pai N, Patil SS. Development and validation of RP-HPLC method for estimation of formoterol fumarate and budesonide in pressurised meter dose inhaler form. Pharm Sinica 2013;4:15-25.

Shah BD, Kumar S, Yadav YC, Seth AK, Ghelani TK, Deshmukh GJ. Analytical method development and method validation of tiotropium bromide and formoterol fumarate metered dose inhaler (Mdi) By using RP-HPLC method. Asian J Biochem Pharma Res 2011;1:145-55.

Gurjar NM, Seth AK, Zanwar A, Patel J, Deshmukh G. Development of first derivative spectroscopy method for estimation of budesonide and formoterol in combined dosage form. Pharma Sci Monitor 2012;3:82-92.

Zanwar AS, Sen DB, Ruhikar DB, Seth AK. Spectroscopic methods for the simultaneous estimation of mometasone furoate and formoterol fumarate in rotacaps. Indo Am J Pharm Res 2014;4:5928-32.

Katari S, Gorule V, Venkata R, Venkata KA. Validated method development for estimation of formoterol fumarate and mometasone furoate in metered dose inhalation form by high performance liquid chromatography. J Anal Bioanal Tech 2012;3:153-7.

Gujarati PZ, Thula KC, Maheshwari DG. Stability indicating HPLC method for simultaneous estimation of mometasone furoate and formoterol fumarate in combined dosage form. Pharmacophore 2014;5:219-30.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. Validation of Analytical Procedures: Text and Methodology ICH Q2(R1); 2005.