A Review on Development and Validation of Analytical Method for Simultaneous Estimation of Formoterol Fumarate Dehydrate and Fluticasone Propionate from Bulk and Dry Powder Inhaler Formulation
Abstract
To compare the effectiveness of formoterol fumarate dihydrate and fluticasone propionate two combination inhaled corticosteroid/long acting beta–agonist product approved for treatment of chronic obstructive pulmonary disease (COPD) in the US with respect to cost, therapy adherence, and related healthcare utilization. UV– method for formoterol fumarate dihydrate (FFD) and fluticasone propionate (FP) is simultaneous equation method, Absorbance ration method, first order derivative method the wavelength of FFD-236nm, FP-215nm, overlay of FFD and FP is 233nm. The process can be used for routine simultaneous analysis of formoterol fumarate dihydrate and fluticasone propionate in dry powder inhalation formulation. Early dry powder inhalers (DPIs) wear designed for low drug doses in asthma and COPD therapy. This study contains carrier- based formulations and lacked efficient dispersion principles. Therefore, partial engineering and powder processing are increasingly applied to achieve acceptable lung deposition with this poorly designed inhaler.
Full Text:
PDFReferences
Skoog DA, Holler FJ, Crouch SR (2007), “Principle of Instrumental Analysis”, 6th edition, Thomson Publications, India, pp. 1−3, 145−147.
ICH, Q2 (R1) (2005), “Validation of analytical procedures: text and methodology”, International Conference on Harmonization, Geneva,
ICH Q2B (1996), “Validation of analytical procedure methodology”, International Conference on Harmonization, Geneva.
ICH Q1A (R2) (2003), “Stability Testing of New Drug Substances and Products”, International Conference on Harmonization, IFPMA, Geneva.
Indian Pharmacopoeia (2007), Govt. of India, Ministry of Health and Family Welfare. New Delhi, The Controller of Publications, Volume 2, pp. 1142−1144.
British Pharmacopoeia (2009), The Stationery Office on behalf of Medicines & Healthcare Products Regulatory Agency(MHRA), Volume 1, pp. 904−906, 913−915.
“The Merck Index”, 13th edition, Merck Research Laboratories, Division of Merck & Co, INC Whitehouse station, NJ, 746(4237),753(4269).
(2005), “Martindale-The complete drug reference”, 34rth edition, Pharmaceutical press, 786.1, 1102.3.
Sethi PD (2001), “High Performance Liquid Chromatography, Quantitative Analysis of Pharmaceutical Formulations”, 1st edition, CBS Publishers and Distributors, New Delhi, pp. 3−11, 116−120.
Munson JW (2001), “Pharmaceutical Analysis, Modern methods-Part B”, International Medical book Distributors, pp. 51−54, Mumbai.
Kasture AV, Mahadik KR, Wadodkar SG, More HN, “Pharmaceutical Analysis- Instrumental Methods”, Volume 2, pp. 6-7,28-30,49,64.
Sethi PD (2001), “High Performance Thin Layer Chromatography, Quantitative Analysis of Pharmaceutical Formulations”, 1st edition, CBS Publishers and Distributors, New Delhi, pp. 3−12, 23, 53−54.
Stahl E (2006), “Thin Layer Chromatography-A Laboratory Handbook”, 2nd edition, Springer, India, pp. 52−66.
Beckett, A. H.; Stenlake, J. B. Practical Pharmaceutical Chemistry-Part-2, CBS Publishers and Distributors, New Delhi, 2002, 275-288.
Malik K, Kumar D, Tomar V, Kaskhedikar S, Soni S (2011), Der Pharmacia Sinica, Volume 2, Issue 6, pp. 77−84.
Yokoi K, Murase K, Shiobara Y (1983), “Life Sci. (United States)”, Volume 33, Issue 17, pp. 1665−1672.
Kakubari I, Dejima H, Miura K, Koga Y, Mizu H, Takayasu T, Yamauchi H, Takayama S, Takayama K (2007), Int. J. Pharm. Sci., Volume 62, Issue 2, pp. 94−95.
Dave, HN, Makwana AG (2010), Int. J. Pharm. Health Sci., Volume 1, Issue 2, pp. 68−76.
Prasad AVSS (2006), Indian J. Technol. Volume 13, pp. 81−83.
Akapo OS, Wegner MMJ, Chromatogr A (2004), Volume 1045, Issue 1, 2, pp. 211−216.
Refbacks
- There are currently no refbacks.