Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Development and Validation of UV Spectrophotometric Method for Simultaneous estimation of Terbinafine hydrochloride and Mometasone furoate in Combined Dosage Form


Affiliations
1 Department of Quality Assurance, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, Changa-388 421, Gujarat, India
     

   Subscribe/Renew Journal


Terbinafine hydrochloride (TH) is a antifungal drug and Mometasone furoate(MF) is a glucocorticoid. This combination of drug is useful for relief of corticosteroid responsive dermatoses where fungal infections are present, suspected, or likely to occur. Accurate, precise, rapid and economical method was developed for the simultaneous estimation of Terbinafine hydrochloride (TH) and Mometasone furoate(MF) in cream dosage form. Method is based on the absorption correction method and wavelengths selected for analysis were 282.0nm (max of Terbinafine hydrochloride) and 248.0 nm (max of Mometasone furoate) respectively, in methanol. The linearity was obtained in the concentration range of 10-70μg/ml for Terbinafine hydrochloride and 1-7μg/ml for Mometasone furoate. The correlation coefficient of Terbinafine hydrochloride and Mometasone furoate were found to be 0.999 and 0.998 respectively. The proposed procedure was successfully applied for the simultaneous determination of both drugs in commercial cream preparation. The results of the analysis have been validated statistically and by recovery studies have confirmed the accuracy of proposed method.

Keywords

Terbinafine Hydrochloride (TH), Mometasone Furoate(MF), Absorption Correction Method, Ultra-violet Spectrometric Method (UV Spectrometric Method).
Subscription Login to verify subscription
User
Notifications
Font Size


  • Drug Profile of Terbinafine hydrochloride, October 2012, http://www.drugbank.ca/drugs/DB00764 (accessed on 20/10/2012)
  • Drug Profile of Mometasone furoate, October 2012, http://www.drugbank.ca/drugs/DB00857 (accessed on 20/10/2012)
  • Beckett AH and Stenlake JB. Practical Pharmaceutical Chemistry. 2th Edition, CBS Publishers:284-300.
  • “ICH Guidelines Q2 (R1)”, October 2012, http://www.ich.org/ fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q 2_R1/Step4/Q2_R1__Guideline.pdf (accessed 10/10/12)
  • British Pharmacopoeia. Her Majesty’s Stationery Office, London, UK, (2), 2011: 2093-2095
  • European Directorate for the quality of medicines and Healthcare European pharmacopoeia7.0 . (2):3047-3048
  • Cardoso SG, Schapoval EES. High-performance liquid chromatographic assay of terbinafine hydrochloride in tablets and creams. Journal of Pharmaceutical and Biomedical Analysis. 19(5) ;1999:809-12.
  • Denouel J, Keller H, Schaub P, Delaborde C, Humbert H. Determination of terbinafine and its desmethyl metabolite in human plasma by high-performance liquid chromatography. Journal of Chromatography B: Biomedical Sciences and Applications. 663(2); 1995:353-9.
  • TagliariI MP. Terbinafine: optimization of a LC method for quantitative analysis in pharmaceutical formulations and its application for a tablet dissolution test. Quím Nova.(33); 2010.
  • Jain AJC, Patel SA, Patel ZN, Patel DT. Development and validation of the UV-spectrophotometric method for determination of terbinafine hydrochloride in bulk and in formulation Pharm Methods 2(3); 2011:198-202.
  • ZHANG J.Study on quality specification of terbinafine hydrochloride suppositories. Chinese Journal of Pharmaceutical Analysis. 2008.
  • Domadiya RS, Jat RK, Chokshi R. Method development and validation for assay of terbinafine hcl in cream by rphplc method. Inventi Rapid: Pharm Ana and Qual Assur. 2012
  • Cardoso SG, Schapoval EES. UV Spectrophotometry and Nonaqueous Determination of Terbinafine Hydrochloride in Dosage Forms. Journal-AOAC international. 82; 1999:830-3.
  • Florea M, Arama CC, Monciu CM. Determination of terbinafine hydrochloride by ion-pair reversed phase liquid chromatography. Farmacia; 2009.
  • Suma.B.V., Kannan.K, Madhavan. V, Nayar CR. HPTLC Method for determination of Terbinafine in the Bulk drug and Tablet dosage form. International Journal of ChemTech Research. 3(2); 2011: 742-748
  • Cardoso SG. Microbiological assay for terbinafine hydrochloride in tablets and creams.
  • Kuzner J, Erzen NK, Kosorok M. Determination of terbinafine hydrochloride in cat hair by two chromatographic methods. Biomedical Chromatography. 15(8); 2001: 497–502.
  • Zehender H, Denouël J, Roy M, Le Saux L, Schaub P. Simultaneous determination of terbinafine (Lamisil) and five metabolites in human plasma and urine by high-performance liquid chromatography using on-line solid-phase extraction. Journal of Chromatography B: Biomedical Sciences and Applications. 664(2); 1995:347-55.
  • Wang C, Mao Y, Wang D, Yang G, Qu Q, Hu X. Voltammetric determination of terbinafine in biological fluid at glassy carbon electrode modified by cysteic acid/carbon nanotubes composite film. Bioelectrochemistry. 72(1); 2008:107-15.
  • Matysová L, Solich P, Marek P, Havlíková L, Nováková L, Šícha J. Separation and determination of terbinafine and its four impurities of similar structure using simple RP-HPLC method. Talanta. 68(3); 2006:713-20.
  • Saharty YS, Fadia NY, Metwally H. Simultaneous determination of terbinafine HCL and triamcinolone acetonide by UV derivative spectrophotometry and spectrodensitometry.
  • Ramesh RR. Simultaneous analysis of rphplc method development and validation of terbinafine and bezafibrate drugs in pharmaceutical dosage form. Pharmacophore. 2(4); 2011:232-8.
  • El-Saharty YS, Hassan NY, Metwally FH. Simultaneous determination of terbinafine HCL and triamcinolone acetonide by UV derivative spectrophotometry and spectrodensitometry. Journal of Pharmaceutical and Biomedical Analysis. 28(3–4); 2002:569-80.
  • British Pharmacopeia. Her Majesty’s Stationery Office, London, UK, (2), 2011, page no. 1487-1489.
  • European Directorate for the quality of medicines and Healthcare European Pharmacopoeia7.0 , (2):2523-2525.
  • USP27, 2004 , official monographs,.1255-1257.
  • Indian Pharmacopoeia. Ministry of health and family welfare, Government of India, New Delhi,(2);2010:1700-1702.
  • Ourique AF; Contri RV; Guterres SS. Set-up of a method using LC-UV to assay mometasone furoate in pharmaceutical dosage forms, Quím Nova.(35); 2006.
  • Vairale AVS, Hima V. B, Sivaswaroop P. Determination of Mometasone Furoate By HPLC In Topical Preparations: Validation,.8(4); 2009.
  • Wulandari LS. TLC Densitometric Determination of Mometasone Furoate in Topical Preparations: Validation. Journal of liquid chromatography and related technologies 1. 26; 2012:109–17.
  • Sahasranaman S, Tang Y, Biniasz D, Hochhaus G. A sensitive liquid chromatography–tandem mass spectrometry method for the quantification of mometasone furoate in human plasma. Journal of Chromatography B. 819(1); 2005:175-9.
  • Shaikh SM, Thusleem OA, Tahir M, Kondaguli AV. A simple RP-HPLC method for the simultaneous quantitation of chlorocresol, mometasone furoate, and fusidic acid in creams. International Journal of ChemTech Research. 47(2); 2009:178-83.
  • Kulkarni AA, Ranjane MN, Ranjane PN. Simultaneous estimation of Nadifloxacin and Mometasone Furoatein topical cream by HPTLC method. Scholars Research Library. 2(3); 2010:25-30.
  • Teng XW, Foe K, Brown KF, Cutler DJ, Davies NM. Highperformance liquid chromatographic analysis of mometasone furoate and its degradation products: Application to in vitro degradation studies. Journal of Pharmaceutical and Biomedical Analysis. 26(2); 2001:313-9.
  • Indian Pharmacopoeia. Ministry of Health and Family Welfare, Government of India, New Delhi.(1);2010:.374

Abstract Views: 770

PDF Views: 2




  • Development and Validation of UV Spectrophotometric Method for Simultaneous estimation of Terbinafine hydrochloride and Mometasone furoate in Combined Dosage Form

Abstract Views: 770  |  PDF Views: 2

Authors

Heta D. Patel
Department of Quality Assurance, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, Changa-388 421, Gujarat, India
Mehul M. Patel
Department of Quality Assurance, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology, Changa-388 421, Gujarat, India

Abstract


Terbinafine hydrochloride (TH) is a antifungal drug and Mometasone furoate(MF) is a glucocorticoid. This combination of drug is useful for relief of corticosteroid responsive dermatoses where fungal infections are present, suspected, or likely to occur. Accurate, precise, rapid and economical method was developed for the simultaneous estimation of Terbinafine hydrochloride (TH) and Mometasone furoate(MF) in cream dosage form. Method is based on the absorption correction method and wavelengths selected for analysis were 282.0nm (max of Terbinafine hydrochloride) and 248.0 nm (max of Mometasone furoate) respectively, in methanol. The linearity was obtained in the concentration range of 10-70μg/ml for Terbinafine hydrochloride and 1-7μg/ml for Mometasone furoate. The correlation coefficient of Terbinafine hydrochloride and Mometasone furoate were found to be 0.999 and 0.998 respectively. The proposed procedure was successfully applied for the simultaneous determination of both drugs in commercial cream preparation. The results of the analysis have been validated statistically and by recovery studies have confirmed the accuracy of proposed method.

Keywords


Terbinafine Hydrochloride (TH), Mometasone Furoate(MF), Absorption Correction Method, Ultra-violet Spectrometric Method (UV Spectrometric Method).

References