Minakshi D. Pawara, Amod S. Patil, Mangesh S. Ghodke
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Minakshi D. Pawara1, Amod S. Patil2*, Mangesh S. Ghodke3
1M. Pharm. Student, Department of Pharmaceutical Chemistry, R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist. Dhule (MS) 425405.
2Assistant Professor, Department of Pharmaceutical Chemistry, R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist. Dhule (MS) 425405.
3Assistant Professor, Department of Pharmaceutical Chemistry, R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist. Dhule (MS) 425405.
Volume - 11,
Issue - 2,
Year - 2021
The purpose of this study is to establish Novel Zero-order UV-Spectrophotometric - absorbance and Zero Order- Area under curve (AUC) methods for estimation of Fenticonazole Nitrate in bulk and vaginal capsules with the application of hydrotropic solubilization phenomenon. Fenticonazole Nitrate is an antifungal drug and it is completely insoluble in water. Pluronic F127 (10% w/v) solution was used as solvent for solubilization of Fenticonazole Nitrate. Maximum absorption for Fenticonazole Nitrate was found to be at wavelength 253nm when dissolved in Pluronic F127 (10% w/v) solution. The methods are based upon measurement of absorbance at 253nm and integration of area under curve for analysis of Fenticonazole Nitrate in the wavelength range of 242.2-261.6nm. The drug followed linearity in the concentration range of 8 - 40µg/mL with correlation coefficient value r2> 0.99 for both methods. The proposed methods were validated for accuracy (% recovery), precision, repeatability and ruggedness, as per ICH guidelines. The proposed methods were applied for qualitative and quantitative estimation of Fenticonazole Nitrate in vaginal capsules and results were found in good agreement with the label claimed. Developed methods can be used for routine analysis of Fenticonazole Nitrate in bulk and Vaginal Capsules.
Cite this article:
Minakshi D. Pawara, Amod S. Patil, Mangesh S. Ghodke. Application of Hydrotropic Solubilization Phenomenon for Estimation of Fenticonazole in Bulk and Vaginal capsules using UV-spectrophotometry Methods. Asian Journal of Pharmaceutical Analysis. 2021; 11(2):113-7. doi: 10.52711/2231-5675.2021.00019
Minakshi D. Pawara, Amod S. Patil, Mangesh S. Ghodke. Application of Hydrotropic Solubilization Phenomenon for Estimation of Fenticonazole in Bulk and Vaginal capsules using UV-spectrophotometry Methods. Asian Journal of Pharmaceutical Analysis. 2021; 11(2):113-7. doi: 10.52711/2231-5675.2021.00019 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2021-11-2-9
1. Fernández-Alba J, Valle-Gay A, Dibildox M, Vargas JA, González J, García M, López LH. Fenticonazole nitrate for treatment of vulvovaginitis: efficacy, safety, and tolerability of 1-gram ovules, administered as ultra-short 2-day regimen. Journal of chemotherapy. 2004, 16(2): 179-86.
2. Veraldi S, Milani R. Topical fenticonazole in dermatology and gynaecology. Drugs. 2008, 68(15): 2183-94.
3. https://pubchem.ncbi.nlm.nih.gov/compound/Fenticonazole-nitrate (Accesed 09/03/2020)
4. European pharmacopeia Department of Health. 2005, 1: 1586-1587.
5. The Merk Index 11thEdition. 1986, 29: 3948.
6. The Martindale and Sweetman Sean. (BB 2734), 383.
7. British Pharmacopeia, The Introduction General Notice Monography Medicinal and Pharmaceutical Substance (A-1). 2005, 1: 818-819.
8. Rathod Bansi H, Chaudhari Geeta V, Shah Priyankaand Khoja Suleman S. Development and Validation of Stability Indicating RP-HPLC Method for Fenticonazole Nitrate in Capsule Dosage Form. European journal of Biomedical and Pharmaceutical Science.2018, 5(5): 701-707.
9. EmanNoaman, Medhat A. Al-GhobashyandHayamLotfy, Investigation of the Profile and Kinetics of Degradation of Fenticonazole Nitrate using Stability-indicating HPLC Assay in Presence of Methyl and Propyl Parabens. Application to Preformulation Studies TACL. 2016, 6(6): 850 - 862.
10. William Speed, long Jeffrey M., Simmonds Roger J.and Enos Trevor A. The Development and Validation of a High-Performance Liquid Chromatography (HPLC)/Tandem Mass Spectrometry Assay for Fenticonazole in Human Plasma and Comparison with an HPLC-UV Method. Rapid Communications in Mass Spectrometry.1995, 9: 1452-1456.
11. Weixing Maoa, Yiya Wang, Wenhui Hua, Feifei Jiao, Hongwei Fanc, Li Ding. Determination of fenticonazole in human plasma by HPLC-MS/MS and its application to pharmacokinetic studies. Journal of Pharmaceutical Analysis. 2016.
12. Zhenbin Feng, Qiaogen Zou, Xiaoheng Tan, Wenjun Che, Zunjian Zhang. Determination of fenticonazole enantiomers by LC-ESI-MS/MS and its application topharmacokinetic studiesin female rats.Arzneimittelforschung, 2011, 61(10): 587-593.
13. Patil MR, Ganorkar SB, Patil AS, Shirkhedkar AA, Surana SJ. Hydrotropic Solubilization in Pharmaceutical Analysis: Origin, Evolution, Cumulative Trend and Precise Applications. Critical Reviews in Analytical Chemistry. 2020, 1-1.
14. Shukla RS, Patel A, Soni ML, Modi V, Jaliwala YA. Quantitative spectrophotometric estimation of cefadroxil using hydrotropic solubilization technique. Asian Journal of Pharmaceutics (AJP): Free full text articles from Asian J Pharm. 2014, 2(3).
15. Patil, MR, Patil, AS. and Shirkhedkar, AA. 2019. Novel and Ecofriendly UV Spectrophotometry Methods for Estimation of Tolvaptan using Hydrotropic Agent. International Journal of Pharmaceutical Chemistry and Analysis. 2019, 6 (4): 115-119.
16. Nwodo NJ, Nnadi CO, Nnadi KI. Development and validation of novel hydrotropic solubilization method for spectrophotometric determination of halofantrine in pure and solid dosage form. Scholar’s Academic Journal of Pharmacy. 2013, 2(4): 298-303.
17. Dahiya J, Singh A, Gupta SK, Kumar B. Spectrophotometric Estimation of Dextromethorphan in Bulk Drug using Hydrotropic Solubilization Technique. Asian Journal of Pharmaceutical Analysis. 2013; 3(3): 90-3.
18. Rani NU, Keerthana K, Mitha M, Kumar SS, Kotamma K, Kiran TM. New spectroscopic method for estimation of atorvastatin tablets using hydrotropic solubilization technique. Asian Journal of Pharmaceutical Analysis. 2015; 5(2): 100-4.
19. Bernard S, Mathew M, Senthilkumar KL. Spectrophotometric method of estimation of Amlodipine besylate using hydrotropic solubilization. Journal of Applied Pharmaceutical Science. 2011 Nov 1; 1(9): 177.
20. Kumar GS, Kumar DA, Babu MN, Debnath S, Ishwarya B, Jyothi G, Kumar DS, Bhavani P, Anjiah D, Kumar GS. Eco-Friendly Spectrophotometric Estimation of Gliclazide using Hydrotropic Solubilization Technique. Asian Journal of Pharmaceutical Analysis. 2019; 9(2): 45-8.
21. Chaudhari SR, Patil AS, Shirkhedkar AA. Studies on derivative spectroscopy and area under curve UV-spectrophotometric methods for estimation of Apremilast in bulk and in-house Tablets. Asian Journal of Pharmaceutical Research. 2018; 8(1): 11-6.
22. Mhaske PD, Bohari BA, Chaudhari SR, Jain PS, Shirkhedkar AA. Implementation UV-Spectrophotometry approach for Determination of Tamsulosin HCl in tablets using area under Curve Technique. Asian Journal of Pharmaceutical Analysis. 2020; 10(2): 86-90.
23. Khan MM, Pritam IP, Chaudhari PJ, Shirkhedkar AA. Development and Validation of Zero and First-Order Derivative Area under Curve Spectrophotometric Methods for the Determination of Pirfenidone in Bulk Material and Pharmaceutical Formulation. Asian Journal of Research in Chemistry. 2019; 12(3): 129-35.
24. Malik A, Firke S, Patil R, Shirkhedkar A, Kalaskar M. Development and Validation of Zero and First-Order Derivative Area under Curve Spectrophotometric Methods for the Determination of Deferiprone in Bulk Material and Capsules. Asian Journal of Pharmaceutical Analysis. 2019; 9 (2): 49-54.
25. Chaudhari MJ, Chaudhari SR, Chalikwar SS, Shirkhedkar AA. Application of area under curve technique for UV-Spectrophotometric determination of Luliconazole in bulk and pharmaceutical formulation. Asian Journal of Pharmaceutical Analysis. 2018; 8(1): 45-8.
26. Mali A, Mali S, Bathe R, Patil M, Tamboli A. Zero order and Area under Curve Spectrophotometric Methods for Determination of Riboflavin in Pharmaceutical Formulation. Asian Journal of Pharmaceutical Analysis. 2016; 6(1): 35-40.
27. ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization 2005.