Development and Validation of the RP-HPLC Method for the Estimation of Chlorocresol and Betamethasone Dipropionate in Semisolid Dosage Formulation
Journal of Pharmaceutical Research International,
Page 12-22
DOI:
10.9734/jpri/2022/v34i38A36212
Abstract
A simple, accurate, reproducible and cost-effective reverse phase HPLC technique for chlorocresol (CRC) as a preservative as well as betamethasone dipropionate (BTD) in bulk drug as well as semi-dose formulations. Snakes were developed during this research. In this method, Discovery HS (150x4.6 mm),was used as the stationary phase and an 80:20 mixture of water and isopropyl alcohol was used as the mobile phase A, and a mixture of acetonitrile plus tetrahydrofuran in the ratio. 70:30 ratio was used as mobile phase B in gradient mode to produce the final product. Approximately 1.00 ml/min of the solution is passed through the chromatograph by pumping it through. The UV detector operates at a wavelength of 240 nm. A validation study in accordance with the ICH Q2 (R1) guidelines is required to demonstrate that the new analytical method meets the reliability characteristics and these characteristics demonstrate the ability of a new analytical method. analysis in maintaining, over time, the basic validation criteria: selectivity, linearity, precision, precision, and specificity. When this method is used for quality control of commercial semi-solid dosage forms of betamethasone dipropionate throughout the day, the stability indicator technique can be used to measure the breakdown of the drug and its products it, as well as to evaluate the results of the tube homogeneity test.
Keywords:
- Chlorocresol
- betamethasone dipropionate
- assay
- HPLC
- validation
- accuracy
How to Cite
Khatawakar, A., Sakat, S., Inamdar, P. and Bagade, O. (2022) “Development and Validation of the RP-HPLC Method for the Estimation of Chlorocresol and Betamethasone Dipropionate in Semisolid Dosage Formulation”, Journal of Pharmaceutical Research International, 34(38A), pp. 12-22. doi: 10.9734/jpri/2022/v34i38A36212.
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Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007;445:866-73.
Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58: 826-50.
Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014;70(3):512–516.
Mason AR, Mason J, Cork M, et al. Topical treatments for chronic plaque psoriasis. Cochrane Database Syst Rev. 2013;3:CD005028.
Sweetman SC. A new species of the plagiaulacid multituberculate mammal Eobaatar from the Early Cretaceous of southern Britain. Acta Palaeontologica Polonica. 2009;54(3):373-84.
Garg T, Rath G, Goyal AK. Comprehensive review on additives of topical dosage forms for drug delivery. Drug Delivery. 2015;22(8):969- 87.
Seif M, Impelido ML, Apps MG, Wheate NJ. Topical cream-based dosage forms of the macrocyclic drug delivery vehicle cucurbit [6] uril. PLOS One. 2014;9(1): e85361.
Denyer SP, Hugo WB, Harding VD. The biochemical basis of synergy between the antibacterial agents, chlorocresol and 2-phenylethanol. International Journal of Pharmaceutics. 1986;29(1):29-36.
Tegazzin V, Scutari E, Treves S, Zorzato F. Chlorocresol, an additive to commercial succinylcholine, induces contracture of human malignant hyperthermia-susceptible muscles via activation of the ryanodine receptor calcium sup 2+ channel. The Journal of the American Society of Anesthesiologists. 1996;84(6):1380-5.
Jahan MS, Islam MJ, Begum R, Kayesh R, Rahman A. A study of method development, validation, and forced degradation for simultaneous quantification of paracetamol and ibuprofen in pharmaceutical dosage form by RP-HPLC method. Analytical Chemistry Insights. 2014;9:75.
Shah Y, Iqbal Z, Ahmad L, Khan A, Khan MI, Nazir S, Nasir F. Simultaneous determination of rosuvastatin and atorvastatin in human serum using RP-HPLC/UV detection: Method development, validation and optimization of various experimental parameters. Journal of Chromatography B. 2011;879(9-10):557-63.
Soman A, Qiu Y, Chan Li Q. HPLC-UV method development and validation for the determination of low level formaldehyde in a drug substance. Journal of chromatographic science. 2008;46(6): 461-5.
Panchale WA, Nimbokar SW, Gudalwar BR, Bakal RL, Manwar JV. RP-HPLC method for simultaneous determination of escitalopram oxalate and flupentixol HCl in tablet dosage form. GSC Biological and Pharmaceutical Sciences. 2021;14(1):169-74.
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Kadam PV, Bhingare CL, Nikam RY, Pawar SA. Development and validation of UV spectrophotometric method for the estimation of curcumin in cream formulation. Pharmaceutical methods. 2013;4(2):43-5.
Sonawane S, Gide P. Application of experimental design for the optimization of forced degradation and development of a validated stability- indicating LC method for luliconazole in bulk and cream formulation. Arabian Journal of Chemistry. 2016;9(2): S1428-S1434.
Malasiya Aditi, Goyal Aditi. Method Development and Validation of RP HPLC Method for Assay and related Substances of Luliconazole in Topical Dosage form. IJPCA. 2017;4(2):46-50.
Desai NJ, Maheshwari DG. UV Spectrophotometric Method for the Estimation of Luliconazole in Marketed Formulation (Lotion). IJPSR. 2014;5(2): 48-54.
Cheng J, Weijun K, Yun L, et al. Development and validation of UPLC method for quality control of Curcuma longa Linn.: fast simultaneous quantitation of three curcuminoids. J Pharm Biomed Anal. 2010;53:43–49.
Daneshgar P, Norouzi P, Moosavi-Movahedi AA, et al. Fabrication of carbon nanotube and dysprosium nanowire modified electrodes as a sensor for determination of curcumin. J Appl Electrochemist. 2009;39:1983–1992.
Dave HN, Mashru RC, Thakkar AR. Simultaneous determination of salbutamol sulphate, bromhexine hydrochloride and etofylline in pharmaceutical formulations with the use of four rapid derivative spectrophotometric methods. Anal Chim Acta. 2007;597:113–120.
Erpina E, Rafi M, Darusman LK, et al. Simultaneous quantification of curcuminoids and xanthorizol in Curcuma xanthorrhiza by high-performance liquid chromatography. J Liq Chromatogram Relat Technol. 2017;40:635–639.
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