Refine your search
Collections
Co-Authors
Year
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z All
Dyade, G K
- AQBD Approach in Chemo Metric Assisted Method Development for the Estimation of Ciprofloxacin and Metronidazole by UV-VIS Spectrophotometry
Abstract Views :71 |
PDF Views:0
Authors
Affiliations
1 Dept of Post Graduate in Pharmaceutical Quality Assurance, SVPM’S College of Pharmacy, Malegaon (BKII) Baramati Dist Pune, Maharashtra, IN
1 Dept of Post Graduate in Pharmaceutical Quality Assurance, SVPM’S College of Pharmacy, Malegaon (BKII) Baramati Dist Pune, Maharashtra, IN
Source
Asian Journal of Pharmaceutical Research, Vol 12, No 3 (2022), Pagination: 185 - 191Abstract
Quality by design is applied for the development of various pharmaceutical processes including analytical methods. By applying QbD approach chemometric based analytical method was developed for the estimation of Ciprofloxacin (CFN) and Metronidazole (MND) by UV-VIS spectrophotometry. Solvent Distilled water was utilised and 271.5nm and 319nm were the wavelength of absorbance measurement for CFN and MND respectively. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of both the drugs was ascertained over the conc range 1 -14mcg/ml. The accuracy of assay was found 98% for CFN and 100.78% for MND; and the precision study was shown acceptable data as %RSD data varied from 0.6369 to 1.3192 for CFN and from 0.5509 to 1.2171 for MND. The developed method is rigid, robust and efficient for the estimation of CFN and MND from the composition of dosage form. QbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage.
Keywords
QbD, Ciprofloxacin, Metronidazole, ICH, simultaneous equation
References
- R. Scherer, Jessica Pereira, Juliate Firme, Mariana Lemos, Mayara Lemos. Determination of Ciprofloxacin in Pharmaceutical Formulations using HPLC Method with UV detection. Indian J of Pharm Sci. 2014; 76(6): 541-544.
- Alison Brayfield. Martindale (The complete drug reference). 39th ed. Pharmaceutical Press London UK. 2017(A). P. A1332, A1414, A1552.
- The Merck Index. An Encyclopaedia of chemicals, drugs and Biological. 15th ed. the Royal Society of Chemistry Cambridge UK. 2013. p. 413, 1142.
- Manoranjan Sabat, Sharada Nalla, Venkateswarlu Goli, Sravan Prasad Macherla, Praveena Kumari Matta, Madhu Chandaka S.. A New Analytical Method Development and Validation for Estimation of Ciprofloxacin in Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2012; 2(4): 116-117.
- Singh Kumar Rakesh, Patel Singh Pankaj, Singh Amar, Roy R.K.. A Simple UV Spectrophotometric Method Development and Validation for Estimation of Ciprofloxacin Hydrochloride in Bulk and Tablet Dosage Form. Asian J. Research Chem. 2012; 5(3): 336-339.
- Marianne Alphonse Mahrouse. Development and validation of UV Spectrophotometric Method for the Simultaneous Determination of Ciprofloxacin Hydrochloride and Metronidazole in Binary Mixture. J of Chem and Pharm Res. 2012; 4(11): 4710-4715.
- Kumar P, Chaudhary M, Juyal V. Difference Spectroscopy Validated Method Development for Ciprofloxacin in Tablet by UV-Spectrophotometer. Research J. Pharm. and Tech. 2009; 2(4): 780-782.
- Ayya Rajendra Prasad, Jayanthi Vijaya Ratna. Development and Validation of Simple UV-Spectrophotometric Method for Determination of Ciprofloxacin Hcl Present in Taste Masking Drug Resin Complex. Int J of Applied Pharm. 2018; 10(3): 37-41.
- K. S. Natraj, Y. Suvarna, G. Prasanti, S. V. Saikumar. UV- Spectrophotometric Method Development and Validation of Simultaneous Estimation of Ciprofloxacin and Ornidazole in Tablet Dosage form. Int Res J of Pharm. 2014; 4(7): 178-181.
- Amir Alhaj Sakur, Hashem A. Dabbeet, Imad Noureldin. Novel Drug Selective Sensors for Simultaneous Potentiometric Determination of both Ciprofloxacin and Metronidazole in Pure form and Pharmaceutical Formulations. Research J. Pharm. and Tech. 2019; 12(7): 3377-3384.
- Amir Alhaj Sakur, Hashem A. Dabbeet, Imad Noureldin. Novel Drug Selective Sensors for Simultaneous Potentiometric Determination of both Ciprofloxacin and Metronidazole in Pure form and Pharmaceutical Formulations. Research J. Pharm. and Tech. 2019; 12(7): 3377-3384.
- I. Carolin Nimila, P. Balan, R. Sathiya Sundar, J. Ashok Kumar, S. Rajasekar. Simultaneous RP-HPLC Estimation of Ciprofloxacin Hydrochloride and Ornidazole in Tablet Dosage Form. Asian J. of Research in Chem. 2011; 4(2): 227-230.
- Janis Vella, Francesca Busutsicl, Nicolette Sammut Bartola, Carmel Sammut, Victor Ferrito, Anthony Serracino- Inglott, Lillian M Azzopardi, Godfrey Laferla. A Simple HPLC-UV Method for the determination of ciprofloxacin in Human Plasma. J of Chromatography B. 2015 (989): 80-85.
- Mohammed E. Abdel-Hamid, Leyla H. Sharaf, Oludotun A. Phillips, Elijah O. Kehinde, Alice Babu. A Rapid Liquid Chromatography-Tandem Mass Spectrometry Method for the Determination of Ciprofloxacin in Rabbits Serum Following Intra- Gastric Dosing: Application to Pharmacokinetics Study. Research J. Pharm. and Tech. 2012; 5(5): 624-631.
- Khawala Salman Abd-Alrassol, H. N. K. AL- Salman, Ekhlas Qanver Jasim, Husseain H. Husseain. Determination and Evaluation of doses of metronidazole in different quantities and formulations with Multiple Spectroscopic Methods. Systematic Review Pharmacy. 2020; 11(5): 130-139.
- Dudhe. P. B., Kamble M. C., Komarwara A., Sonavane A. M., Van S. Development and Validation of first Order Derivative Method for Metronidazole in Bulk and Tablet Using UV- Spectroscopy. Int J of Research in Chem and Tech. 2016; 9(4): 140-144.
- S. K. Mastanamma, K. Sravani, T. Anil. UV Differential Spectrophotometric Method for Estimation of Metronidazole in bulk and Pharmaceutical Formulations. Rasayan J. Chem. 2015; 8(3): 303-309.
- Joyani Das, Manabendra Dhua. UV Spectrophotometric Assay Method Development and Validation of Metronidazole in Bulk and Tablet Formulation. J of Pharma Sci Tech. 2014; 3(2): 106- 109.
- Nikita V Patel, Arun M. Prajapati. Q-Absorbance Ratio Spectrophotometric method for the Simultaneous Estimation of Metronidazole and Ciprofloxacin in their Combined Dosage form. J of Pharm Sci and Bio Scientific Res. 2012; 2(3): 118-122.
- A. Veeshma, S. Priyanka, K. Praveen and K. Sirisha. Simultaneous Estimation of Ciprofloxacin and Metronidazole in Bulk and Tablet Formulation by UV- Spectrophotometry. Int J of Pharm Sci and Research. 2021; 12(4): 2247-2256.
- Ruchi Jain, Nilesh Jain, Deepak Kumar jain, Vijay Kumar Patel, Harish Rajak, Surendra Kumar Jain. Novel UV-Spectrophotometer Methods for Quantitative Estimation of Metronidazole and Furazolidon Using mixed Hydrotropy Solubilisation. Arabian J of Chem. 2013: 9(3); 151-156.
- Tabassum H. Aaraf, Hasumati A. Raj, Vineet C. Jain, Vishnu Sutariya. Development and Validation of Ratio Derivative Spectrophotometric Method for Estimation of Metronidazole Benzoate and related Impurity in Bulk and Pharmaceutical Formulation. Asian J. Pharm. Tech. 2015; 5 (2): 66-70.
- Rajesh Kumar Maheshwari, Masheer Ahmed Khan, Nupur Maheshwari, Neelesh Maheshwari. Solid as solvent- Novel Spectrophotometric Analytical Method for Metronidazole Tablets using Solids (Eutectic Liquid of Phenol and Niacinamide) as Solubilizing Agents (Mixed Solvency Concept). Research J. Pharm. and Tech. 2016; 9(6): 705-708.
- British Pharmacopoeia. Medicines and Healthcare products regulatory agency London; 2015. pp. I-495, II-281.
- Indian Pharmacopoeia, Govt. of India, ministry of Health and family welfare, The Indian pharmacopoeia commission Ghaziabad. 7th ed (II, III). 2014; pp.1399. 4751.
- ICH Expert working group. ICH Harmonized Tripartite Guideline- Pharmaceutical Development Q 8 R2. In current step 4 version. 2009; p. 1-28.
- ICH Expert working group. ICH Harmonized Tripartite Guideline- Quality Risk Management Q 9. In current step 4 version. 2005; p. 1-23.
- ICH Expert working group. ICH Harmonized Tripartite Guideline- Pharmaceutical Quality System Q 10. In current step 4 version. 2008; p. 1-21.
- ICH Expert working group. ICH Harmonized Tripartite Guideline-Validation of analytical procedures: Text and methodology Q 2 R1. In current step 4 version.2005; p. 1-17
- Schweitzer M, Pohl M, Hanna-Brown M, Nethercote P , Bormanare P, Hansen G, et al. Implications and opportunities of applying QbD principles to analytical measurements. Pharm Technology. 2010; 34: 12-29.
- Vogt F G, Kord A S. Development of quality-by-design analytical methods. J of Pharm science. 2011; 100: 797-812.
- Bhatt D A, Rane S I. QbD approach to analytical RP-HPLC method development and its validation, Int J of Pharma Science. 2011; (3): 179-187.