Author(s):
Pooja Kaushal, Shiv Kumar Kushawaha, Manish Majumder, Mahendra Singh Ashawat
Email(s):
shiv.kushawaha@gmail.com
DOI:
10.52711/2231-5675.2023.00026 
Address:
Pooja Kaushal1, Shiv Kumar Kushawaha1*, Manish Majumder2, Mahendra Singh Ashawat1
1Laureate Institute of Pharmacy, Kathog, Kangra, H.P. 176031.
2Adichunchanagiri University, Karnataka.
*Corresponding Author
Published In:
Volume - 13,
Issue - 3,
Year - 2023
ABSTRACT:
A simple, sensitive, accurate, precise, and reproducible UV- spectrophotometric method and RP-HPLC methods were developed and validated for the estimation of Famotidine and Ofloxacin in bulk drug and pharmaceutical formulation. The Linearity regression was detected and shows a good linear relationship; in the concentration range of 10-50µg/mL (R2 >0.9908) for famotidine and 10-50µg/mL (r2>0.9913) for ofloxacin. The UV – spectrophotometric estimation was carried out by the first-order derivative spectrophotometric method and absorbance were recorded at 273 and 280nm. Beers range were found to be 5-50µg/mL, respectively for both drugs while, correlation coefficient r2 > 0.9988 and 0.9941 for famotidine and ofloxacin. The isoabsorptive point was found to be 274nm in HPLC optimized mobile phase composition, potassium dihydrogen orthophosphate: methanol (60:40). Chromatographic condition consisted of mobile phase potassium dihydrogen orthophosphate buffer pH 2.3, methanol (60:40v/v), run time 30 min, C-18 column (ODS Hypersil) and flow rate 0.8mL/minute. The retention time for famotidine and ofloxacin were found to be 2.44 min, 7.99 min. respectively, and detection at ?max 274nm for both drugs (overlain spectra). The UV methods and RP-HPLC showed good reproducibility and recovery with the percent relative standard deviation (RSD) less than 5%. As per ICH guidelines, the developed method was validated for linearity, accuracy, precision, Sandell's sensitivity, and repeatability proving its utility in the estimation of famotidine and ofloxacin in house tablet formulation.
Cite this article:
Pooja Kaushal, Shiv Kumar Kushawaha, Manish Majumder, Mahendra Singh Ashawat. Validated Analytical Method for Multicomponent Analysis of Famotidine and Ofloxacin in Bulk drug and Tablet Formulation by using UV-Visible Spectrophotometer and RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2023; 13(3):162-0. doi: 10.52711/2231-5675.2023.00026
Cite(Electronic):
Pooja Kaushal, Shiv Kumar Kushawaha, Manish Majumder, Mahendra Singh Ashawat. Validated Analytical Method for Multicomponent Analysis of Famotidine and Ofloxacin in Bulk drug and Tablet Formulation by using UV-Visible Spectrophotometer and RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2023; 13(3):162-0. doi: 10.52711/2231-5675.2023.00026 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2023-13-3-2
REFERENCE:
1. K. Lucija, J. Jelena, S. Robert, R.L. Nikola, V. Aleksandar. Peptic Ulcer Disease: A Brief Review of Conventional Therapy and Herbal Treatment Options. J Clin Med. 2019; 8(2): 179.
2. B. Tsvetkova, V. Maslarska, L. Peikova. An overview of determination of Famotidine by different analytical methods. Pharmacia. 2015; 62: 1.
3. K.D. Tripathi. Essentials of medical pharmacology, 8th edition, Jaypee Brothers Medical publication (P) Ltd: New Delhi, 2019; 698 p.
4. F.S.K. Barar. Essential of pharmacotherapeutics, 8th edition Revised, S Chand and Company Ltd, New Delhi. 2013; 537p.
5. S. Budavari, M. J. O’Neill, A. Smith, P. E. Heckelman, J. F. Kinneary. The Merck Index: An Encyclopedia of Chemicals, Drugs and Biologicals, 13th Edn., Merck and Co. Inc., Whitehouse Station, NJ. 2001; 6800.
6. D.F. Jitendra, P.M. Harshal, Y.C. Rajesh, R.P. Vijay. Simultaneous Spectrophotometric Estimation of Ofloxacin and Ketorolac Tromethamine in Ophthalmic Dosage Form. International Journal of Chem Tech Research. 2009; 1(2): 189-194.
7. The Indian Pharmacopoeia. Government of India ministry of Health and Family Welfare. 2007; 1736-2370.
8. The United State Pharmacopoeia. National formulary, XX, Rockville MD: The US Pharmaceutical Convention, 2000; 707-1216.
9. British Pharmacopoeia The Department of Health, Social Services and Public Safety. 2005; 1441-2466.
10. M.V. Krishna, G. Madhavi, L. A. Rama Prasad, D. Gowri Sankar. Impurity profiling of Famotidine in bulk drugs and pharmaceutical formulations by RP-HPLC method using ion pairing agent. Der Pharmacia Lettre. 2010; 2 (3): 1-11.
11. G. Krishnaveni, P.V. Sathyannarayana. Simultaneous determination of famotidine and ibuprofen in combined pharmaceutical dosage form by RP-HPLC method. International Journal of Pharma Bio Science. 2013; 4(3): 655 – 662.
12. B. Anand, G. Pramod, K. Neelaveni, T. Prasanthi, R.A. Lakshmana. Development and Validation for the Determination of Famotidine by RP-HPLC Method in Pure and Tablet Dosage Form. Operant Innovations in Biologicals and Allied Sciences. 2017; 1(2): 64-70.
13. T. Vijaya Bhaskara Reddy, C. Rambabu, N. Sowjanya Reddy, S. Ravi Prakash Reddy, G. Ramu. Assay of famotidine in API and dosage forms by UV direct and UV derivative spectrophotometric methods. Der Pharmacia Sinica. 2014; 5(1), 57-65.
14. B. W. Yogita, D. P. Dipak, N. S. Joshi, S. B. Bari. Development and Validation of difference Spectrophotometric method for the estimation of Famotidine in bulk and Pharmaceutical dosage Form. International Journal of Drug Development and Research. 2013; 5(2): 272-277.
15. B.G. Tsvetkova, L. Peikova, K. Bistra, I.P. Asenova. HPLC assay of model formulations containing diclofenac sodium and famotidine. Journal of Chemical and Pharmaceutical Research. 2015; 7(4): 589-594.
16. R.R. Yarram, K.K. Kakumani, K. Mukkanti. RP-UPLC method development and validation for the simultaneous estimation of ibuprofen and famotidine in pharmaceutical dosage form. Pharm Methods. 2012; 3(2): 57–6.
17. V.K. Ahirrao, R.P. Pawar. Simultaneous Quantification of Famotidine and Ibuprofen in Pharmaceutical Dosage by Using Validated Stability Indicating LC Method. Research Journal of Pharmaceutical Sciences. 2013; 2(4): 1-9.
18. Manjula. Simultaneous Determination and Validation of Ofloxacin and Ornidazole in Combined Dosage Pharmaceutical Formulation by RP-HPLC Method. Master’s thesis, J.K.K. Munirajah College of Pharmacy, Komarapalayam, 2018, 54p.
19. K.S. Khandagle, S.V. Gandhi P.B. Deshpande, N.V. Gaikwad. A Simple and sensitive RPHPLC method for simultaneous estimation of cefixime and ofloxacin in combined tablet dosage form. Int J Pharm Sci. 2011; 3(1): 46-48.
20. M. A. Abbasi, S. Ali, H. M. Ashfaq, M. Z. Qureshi, S. Z. Siddiqui, V. U. Ahmad. 2,7- Dicholorofluorescein: a suitable complexing agent for the spectrophotometric determination of ofloxacin in pure and pharmaceutical dosage forms. J. Chem. Soc. Pak. 2010; 32: 172–175.
21. S. Datri, A. Lakshmana Rao, S. Raja Sajnadh, S. Geethika, S. Bhavani Devi, T. Vastsavi Sai. Development and Validation of UV Spectroscopic Methods for Simultaneous Estimation of Ofloxacin and Tinidazole in Pharmaceutical Dosage Form. Indian Research Journal of Pharmacy and Science. 2018; 5(2): 1462-1469.
22. T. Ohkubo, M. Kudo, K. Sugawara. Determination of ofloxacin in human serum by high-performance liquid chromatography with column switching. J. Chromatogr. 1992; 573(2): 289–293.
23. ICH Q2 (R1). Validation of Analytical Procedures: Text and Methodology, 2005.
24. R. Bairam, H. Kumar Tatapudi, N. Gajji, S. Harun Rasheed. UV Spectrophotometric and HPLC Method for Quantification of Ticagrelor in Bulk and Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2022; 12(3):159-5.
25. A. M. Kashid, P. P. Polshettiwar, K. M. Bhosale. Analytical Method Development and Validation of Teriflunomide Active Pharmaceutical Ingredient by RP-UHPLC. Asian Journal of Pharmaceutical Analysis. 2022; 12(3):166-2
26. P. Juhee, H. Chorawala, Z.R. Dedania, S.M. Vijendraswamy. Development and Validation of UV Spectroscopic Method for Simultaneous Estimation of Doxofylline and Terbutaline Sulphate in Combined Dosage Form. Asian J. Pharm. Ana. 2015; 5(2): 74-78.
27. Suman Pattanayak, A. Alekhya Prasanna, Ch. Kiranmayi, K. Padmalatha. Analytical UV Spectroscopic Method Development and Validation for the Estimation of Mycophenolate Mofetil. Asian J. Pharm. Ana. 2015; 5(4): 209-213
28. F. Dosani, N. Hakam, A. Vyawahare, S. Patharkar, K. Gajbhiye. Development and Validation of Stability Indicating Method of UV-Spectrophotometry for the Estimation of Flavoxate in Bulk and Tablet Dosage form. Asian Journal of Pharmaceutical Analysis. 2022; 12(1): 6-2.
29. M. Pravalika, J. Archana. A New Validated Spectroscopic Method for the estimation of Sodium Benzoate in Soft drinks. Asian Journal of Pharmaceutical Analysis. 2022; 12(1):13-6.
30. C. Mathew, S. Varma. Green Analytical Methods based on Chemometrics and UV spectroscopy for the simultaneous estimation of Empagliflozin and Linagliptin. Asian Journal of Pharmaceutical Analysis. 2022; 12(1):43-8.
31. B. Bhavya, P. Nagaraju, V. Mounika, G. Indira Priyadarshini. Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Albendazole and Ivermectin in Pharmaceutical Dosage form. Asian J. Pharm. Ana. 2017; 7(1): 6-14.
32. Sushil D. Patil, Sunil V. Amurutkar, C.D. Upasani. Development and Validation of Stability Indicating RP-HPLC Method for Empagliflozin. Asian J. Pharm. Ana. 2016; 6(4): 201-206.
33. B. Thangabalan, M. Salomi, N. Sunitha, S. Manohar Babu. Development of validated RP-HPLC method for the estimation of Itraconazole in pure and pharmaceutical dosage form. Asian J. Pharm. Ana. 2013; 3(4): 119-123.