VALIDATION STUDY OF STEROIDAL DRUGS (DEXAMETHASONE AND BETAMETHASONE) BY U.V. SPECTROPHOTOMETRIC METHOD
DOI:
https://doi.org/10.22159/ajpcr.2018.v11i7.22794Keywords:
Dexamethasone, Betamethasone, Method validation, Ultraviolet spectroscopy, Accuracy, PrecisionAbstract
Objective: The present investigation involves development and validation of ultraviolet (UV) spectroscopic method for estimation of dexamethasone and betamethasone in a pharmaceutical dosage as per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
Method: Betamethasone and dexamethasone were dissolved in 50 mL Methanol: water (1:2) and 50 mL distilled water, respectively. The method was validated for accuracy, precision, linearity, ruggedness, and robustness to check its consistency.
Result: The λmax or the absorption maxima of both the drugs was found to be 241 nm. A linear response was observed in the range of 10–20 μg/mL.
Conclusion: The method could be applied for the analysis of marketed tablets and also can be used for the routine analysis of dexamethasone and betamethasone in bulk formulations using UV method. It is suitable for the intended purpose especially in forensic science laboratories and other laboratories involved in the pharmaceutical analysis.
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Susmitha A, Kalarani DH, Venkatesh P1, Reddy KR. Analytical method development and validation of aceclofenac in pharmaceutical dosage dorm by uv spectroscopy technique. Int J Pharm Pharm Sci 2013;5:975-1491.
Chen Q, Zielinski D, Chen J, Koski A, Werst D, Nowak S, et al. A validated, stability-indicating HPLC method for the determination of dexamethasone related substances on dexamethasone-coated drug-eluting stents. J Pharm Biomed Anal 2008;48:732-8.
Liu H, Chen X, Zhang S, Qu L, Zhao Y, Liu H, et al. Separation and determination of dexamethasone sodium phosphate in cochlear perilymph fluid by liquid chromatography with ultraviolet monitoring and electrospray ionization mass spectrometry characterization. J Chromatogr B Analyt Technol Biomed Life Sci 2004;805:255-60.
Zurbonsen K, Bressolle F, Solassol I, Aragon PJ, Culine S, Pinguet F, et al. Simultaneous determination of dexamethasone and 6 beta-hydroxydexamethasone in urine using solid-phase extraction and liquid chromatography: Applications to in vivo measurement of cytochrome P450 3A4 activity. J Chromatogr B Analyt Technol Biomed Life Sci 2004;804:421-9.
Zhang M, Moore GA, Jensen BP, Begg EJ, Bird PA. Determination of dexamethasone and dexamethasone sodium phosphate in human plasma and cochlear perilymph by liquid chromatography/tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2011;879:17-24.
Earla R, Boddu SH, Cholkar K, Hariharan S, Jwala J, Mitra AK, et al. Development and validation of a fast and sensitive bioanalytical method for the quantitative determination of glucocorticoids – quantitative measurement of dexamethasone in rabbit ocular matrices by liquid chromatography tandem mass spectrometry. J Pharm Biomed Anal 2010;52:525-33.
Li C, Wu Y, Yang T, Zhang Y. Rapid simultaneous determination of dexamethasone and betamethasone in milk by liquid chromatography tandem mass spectrometry with isotope dilution. J Chromatogr A 2010;1217:411-4.
Oliveira TM, Ribeiro FW, Soares JE, de Lima-Neto P, Correia AN. Square-wave adsorptive voltammetry of dexamethasone: Redox mechanism, kinetic properties, and electroanalytical determinations in multicomponent formulations. Anal Biochem 2011;413:148-56.
Amin AS, Issa YM. Extraction-spectrophotometric method for the determination of betamethasone in pure form and in pharmaceutical formulations. Analyst Lett 1997;1:69-78.
Bahlul ZA, Nagiat TH, Babu RC, Sreekanth N, Prakash K. Development and validation of a new spectrophotometric method for the determination of betamethasone in bulk and pharmaceutical dosage forms. Int J Pharm Biomed Res 2010;1:87-9.
Ankam R, Mukkanti K, Durgaprasad S, Khan M. Simultaneous HPLC determination of butenafine hydrochloride and betamethasone in a cream formulation. Indian J Pharm Sci 2009;71:547-51.
Xiao KP, Xiong Y, Rustum AM. Quantitation of trace betamethasone or dexamethasone in dexamethasone or betamethasone active pharmaceutical ingredients by reversed-phase high-performance liquid chromatography. J Chromatogr Sci 2008;46:15-22.
Wang L, Yang YY, Chung TS, Chen XQ. Determination of betamethasone disodium phosphate in the in vitro media of PLGA microspheres by high-performance liquid chromatography. J Pharm Biomed Anal 2002;28:629-35.
González L, Yuln G, Volonté MG. Determination of cyanocobalamin, betamethasone, and diclofenac sodium in pharmaceutical formulations, by high performance liquid chromatography. J Pharm Biomed Anal 1999;20:487-92.
Maron N, Cristi EA, Ramos AA. Determination of betamethasone 17-benzoate in lipophylic vehicles by reversed-phase high-performance liquid chromatography. J Pharm Sci 1988;77:638-9.
Li M, Lin M, Rustum A. Application of LC-MS(n) in conjunction with mechanism-based stress studies in the elucidation of drug impurity structure: Rapid identification of a process impurity in betamethasone 17-valerate drug substance. J Pharm Biomed Anal 2008;48:1451-6.
ICH harmonized Tripartie Guideline. Text on Validation of Analytical Procedures. Q2A and Q2B; 1995. p. 1-7.
Manjunath S, Chouhan V, Sandeep S. Spectrophotomeric estimation of levosulpiride in bulk and formulations. Int J Pharm Pharm Sci 2011;3:135-7.
Wamorkar V, Manjunath SY, Verma MM. Development and validation of UV spectroscopic method for determination of metoclopramide hydrochloride in bulk and tablet formulation. Int J Pharm Pharm Sci 2011;3:171-4.
Friedrich RB, Ravanello A, Cichota LC, Rolim CM, Beck RC. Validation of a simple and rapid UV spectrophotometric method for dexamethasone assay in tablets. QuÃmica Nova 2009;32:1052-4.
Mustarichie R, Levitaa J, Musfiroha I. Spectrophotometric validation method of dexchlorpheniramine maleat and betamethasone. Int J Res Dev Pharm Life 2014;3:1096-105.
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