Development and Validation of Advanced UV-Spectrophotometric Methods and a RP-HPLC Method for the Simultaneous Estimation of Beclomethasone Dipropionate and Formoterol Fumarate Dihydrate in Bulk and Pharmaceutical Dosage Forms
Abstract
The presented research work aims to develop and validate UV-Spectrophotometric as well as RP-HPLC methods for the simultaneous estimation of Beclomethasone Dipropionate (BDP) and Formoterol Fumarate Dihydrate (FFD). These methods offer a higher degree of sensitivity than the already present methods of analysis. By implementing advanced spectroscopic techniques such as Dual Wavelength Method and First Derivative Spectroscopy it is found that the sensitivity of the methods is increased. The linearity of both the methods was in the range of 10µg/ml to 50µg/ml for BDP and 1µg/ml to 5µg/ml for FFD, with an r2 value of 0.999 and 0.9988 respectively for Dual Wavelength Method and First Derivative Method. The LOD values of Dual Wavelength Method and First Derivative Method were found to be 0.127µg/ml and 0.016µg/ml respectively. A RP-HPLC Method has also been developed and validated for this combination having a linearity in range of 50µg/ml to 250µg/ml for BDP and 1.5µg/ml to 7.5µg/ml for FFD. The r2 value of BDP and FFD was found to be 0.9995 and 0.994. The application of this RP-HPLC Method may also be extended for the simultaneous estimation of a triple combination of Beclomethasone Dipropionate, Formoterol Fumarate and Glycopyrronium Bromide (GPB).
Keywords: Beclomethasone, Formoterol, Glycopyrrolate, Dual-Wavelength-Method, First-Derivative, Spectroscopy, RP-HPLC
Keywords:
Beclomethasone, Formoterol, Glycopyrrolate, Dual-Wavelength-Method, First-Derivative, Spectroscopy, RP-HPLCDOI
https://doi.org/10.22270/jddt.v10i5.4382References
Liugino Calzetta, Maria Gabriella Matera, Francesco Facciolo, Mario Cazzola and Paolo Rogliani; Beclomethasone Dipropionate and Formoterol Fumarate Synergistically interact in hyper-responsive medium bronchi and small airways; Respiratory Research 2018; 19:65; 1-13
Parth D. Shah and Shailesh Koradia; Simultaneous determination of Beclomethasone Dipropionate and Formoterol Fumarate in Rotacap dosage form using two different spectrophotometric methods; World Journal of Pharmacy and Pharmaceutical Sciences 2014; 3 (5); 611-623
Vijaykumar K. Parmar, Hetvi N. Patel and Bhavin K. Patel; Sensitive and Robust method for simultaneous determination of Beclomethasone Dipropionate and Formoterol Fumarate Dihydrate in Rotacaps; Journal of Chromatographic Science 2014; 52; 1255-1266
D. De Orsi, L Gagliardi, F. Chimenti, and D. Tonelli; HPLC Determination of Beclomethasone Dipropionate and its degradation products in bulk drug and pharmaceutical formulations; Analytical Letters 2014 Taylor and Francis; 28:9, 1655-1663
A. Papi, P.L. Paggiaro; Beclomethasone/Formoterol versus Budesonide/Formoterol combination therapy in asthma; On behalf of the inhaled combination asthma treatment versus symbicort study group; Eur Respir J 2007; 29: 682-689
Beckett A.H, Stenlake J.B; UV-visible Spectrophotometry: Practical Pharmaceutical Chemistry; 4th edition Part-II; C.B.S. Publishers, Delhi 2001; 285-97
ICH Harmonised Tripartite Guideline; Validation of Analytical Procedures: Text and Methodology Q2(R1); 1-13
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