ABSTRACT:
A simple, sensitive, accurate, rapid and economical UV Spectrophotometric method was developed and validated of Simethicone and Cinitapride in pure drug and tablet dosage form. The absorbance was measured at 276.8nm using Ether and Dimethylsulfoxide as solvent system. It obeyed Beer’s law at the concentration range of 2-14µg/ml and 2-12µg/ml with coefficient of correlation (r2) of 0.998 and 0.9993. Limit of detection (LOD) was found to be 1.226µg/ml and 1.224µg/ml and Limit of quantitation (LOQ) was found to be 5.226 µg/ml and 4.088µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.
Cite this article:
Husnain Fathima, Zaiba Khannum. Method Development and Validation of Simethicone and Cinitapride by UV- Spectroscopy and RP-HPLC in Solid Dosage Forms. Asian Journal of Research in Chemistry.2025; 18(3):142-8. doi: 10.52711/0974-4150.2025.00023
Cite(Electronic):
Husnain Fathima, Zaiba Khannum. Method Development and Validation of Simethicone and Cinitapride by UV- Spectroscopy and RP-HPLC in Solid Dosage Forms. Asian Journal of Research in Chemistry.2025; 18(3):142-8. doi: 10.52711/0974-4150.2025.00023 Available on: https://www.ajrconline.org/AbstractView.aspx?PID=2025-18-3-5
REFERENCES:
1. Pandey K P, Patel M, Manigquha A, Wadhwa P, Sahu K S. Simultaneous estimation for Dicyclomine HCl and Simethicone in bulk and oral liquid drop formulation: an RP-HPLC method development and validation. Future Journal of Pharmaceutical Sciences. 2020; 6(12): 2-8
2. https://www.nhs.uk/medicines/simeticone/#:~:text=Simeticone%20Brand%20names%3A%20Wind%2Deze,and%20how%20to%20take%20it.
3. https://www.pdr.net/Mobile/Pages/drug-summary/Gas-X-simethicone-2675
4. Thangabalan B, Prabahat E A, Kalaichelvis R, Kumar V P. Spectrophotometric Method for Determination of Cinitapride in Pure and its Solid Dosage. E-Journal of Chemistry. 2009; 6(1): 21-24
5. https://www.1mg.com/generics/cinitapride-211489?wpsrc=Google+Organic+Search
6. Schrey D, Groll H A. Side Effects of Drugs Annual. 2010; 32
7. Niraimathi V., Suresh JA. RP-HPLC method development and validation for the estimation of cinitapride and omeprazole in solid oral dosage form. International Journal of Pharmacy and Pharmaceutical Sciences. 2012; 4(2): 342-344.
8. Latha BM, Noorjahan MD. Madhukar A. A New RP-HPLC method for the simultaneous estimation of Magaldrate and Simethicone in bulk and tablet dosage form as per ICH guidelines. J Syn Natu Chem. 2018; 3(1): 31-34.
9. Satyanarayana P., Pavankumar KLNSVK., Srinivasa Rao A., Sastry GS. Method development and validation for simultaneous estimation of ranitidine, domperidone and simethicone in bulk and pharmaceutical Dosage form by using RP-HPLC method. World Journal of Pharmacy and Pharmaceutical Sciences. 2015; 4(11): 1146-1158
10. Pandey PK, Patel M., Manigauha A., Wadhwa Pand Sahu SK. Simultaneous estimation for Dicyclomine HCl and Simethicone in bulk and oral liquid drop formulation: an RP-HPLC method development and validation. Future Journal of Pharmaceutical Sciences. 2020; 6(12): 2-8.
11. Mali DA, Manojkumar P. Estimation of Rantidine in Bulk and Formulation by First Order Derivative Area Under Curve UV-Spectrophotometry Methods. AJPA. 2015; 5(2): 61-66
12. PP Pardeshi, MV Gaware, BK Dhamak. Development and Validation of RP-HPLC Method for the Estimation of Bilsatine from bulk and Formulation. AJPA. 2020; 10(2):109-111
13. S. Subramanya Raj Urs, Bindu M, Ramyashree D, Sowmya K N. Estimation of Cetirizine Hydrochloride in pharmaceutical preparation. AJPA. 2020; 10(4) 185-188
14. A M Beltagi, I A Lashin, W A Essa, A A Hathoot, M. Abdel Azzem. Evolution and effectiveness of HPLC technique for rapid estimation of an antiallergic agent Bilastine. AJPA. 2021; 11(2): 57-62
15. Patel K K, Patel M A, Patel N C. A new simple RP-HPLC method development, Validation and Forced degradation studies of Bilastine.AJPA.2021;11(3)183-187
16. Harikrishnan N, R Deepthi, V Manjusha, Vani S P, Jyothi A V M. Development and Validation of UV spectrophotometric methods of Loratadine in bulk and pharmaceutical formulation. AJPA. 2010; 3(2): 305-307
17. Harikrishnan N, Muralikrishna U, Vani S P, Jyothi AVM, Ranjithkumar V, Haribaskar. Development and Validation of UV spectrophotometric method of levocetirizine dihydrochloride in bulk and pharmaceutical formulation. AJPA. 2010; 3(3): 539-541
18. Agarwal P N, Teli E N. A validated and simplified RP-HPLC method for Estimation of Ebastine from bulk drugs. AJPA. 2011; 4(7): 1164-1167
19. Sankar KSA, Baskar NG, Nagavalli D, Anandakumar K, Vetrichelvan T. Simultaneous Estimation of Montelukast Sodium and Levocetirizine hydrochloride from tablet dosage form. AJPA. 2009; 2(4): 743-745
20. Choudhari PV, Kale NA, Polshettiwar AS, Sutar S A, Patel M D, Kuchekar SB. Derivative and Absorption factor Spectrophotometric estimation of Montelukast Sodium and Levocetirizine dihydrochloride from pharmaceutical formulation. AJPA. 2011; 4(3): 389-392