Development and Validation of RP-HPLC Method for Oral Printed Films of Ketorolac Tromethamine

  • Priya Dule Gurunanak College of Pharmacy,Khasra No. 81/1, MauzaNari, Near Dixit Nagar, Kamptee Road, Nagpur, Maharashtra, India
  • Vaishali Kilor Gurunanak College of Pharmacy,Khasra No. 81/1, MauzaNari, Near Dixit Nagar, Kamptee Road, Nagpur, Maharashtra, India

Abstract

For the analysis of Ketorolac Tromethamine in Oral film formulation, a simple, precise, and accurate method was developed and validated. On a Kromosil C18 column (150 cm 4.6 mm 5), an isocratic HPLC analysis was performed. The chemical was isolated using a solution of A 55:45 V/V methanol and ammonium dihydrogen phosphate buffer with a pH of 3.0 was used. Adjusted with 1.5 mL/min flow of O-phosphoric acid as the mobile phase UV detection was carried out. Photo diode array detection was used at 314 nm. The retention time was discovered to be 6.08 minutes. The system suitability criteria, such as theoretical plate count, tailing, and percentage, should be kept to a minimum. The RSD between six standard injections was within the acceptable range. The procedure was tested and found to be valid. According to the ICH guidelines over the concentration range of 50-150 gm/L, calibrations were linear. The correlation coefficient (r) of 0.999 indicates this. The method's resilience was tested by systematically changing the chromatographic settings. The approach described may be used for routine quantitative analysis.


 

Keywords: Ketorolac Tromethamine, RP-HPLC Method, PDA detector.

Downloads

Download data is not yet available.

Author Biographies

Priya Dule, Gurunanak College of Pharmacy,Khasra No. 81/1, MauzaNari, Near Dixit Nagar, Kamptee Road, Nagpur, Maharashtra, India

Gurunanak College of Pharmacy,Khasra No. 81/1, MauzaNari, Near Dixit Nagar, Kamptee Road, Nagpur, Maharashtra, India

Vaishali Kilor, Gurunanak College of Pharmacy,Khasra No. 81/1, MauzaNari, Near Dixit Nagar, Kamptee Road, Nagpur, Maharashtra, India

Gurunanak College of Pharmacy,Khasra No. 81/1, MauzaNari, Near Dixit Nagar, Kamptee Road, Nagpur, Maharashtra, India

References

Archana, D.K., Keshao, P.G., Bakad, B.V., Channawa, M.A., Chandewar, A.V, Rupesh, S. K. ,. n.d. “Formulation and Development of Enteric Coated Dosage Form Using Ketorolac Tromethamine.” 2010 2:126–35.
2. Dixit, R. P., and S. P. Puthli. 2009. “Oral Strip Technology: Overview and Future Potential.” Journal of Controlled Release 139(2):94–107. doi: 10.1016/j.jconrel.2009.06.014.
3. DrChandewar A.V, Dewani A. P. n.d. “Absorption Ratio Method For The Estimation Of Moxifloxacin Hcl & Ketorolac Tromethamine In Their Combined Dosage Form by Uv-Visible Spectroscopy.” International Standard Serial Number 3(7):21–26.
4. Genç, Lütfi, ErdenGüler, and Nahed Hegazy. 1997. “Film-Coated Enteric Tablet Formulation of Ketorolac Tromethamine.” Drug Development and Industrial Pharmacy 23(10):1007–11. doi: 10.3109/03639049709149154.
5. ICH, 2005. n.d. International Conference on Harmonisation (ICH) Q2 (R1): Validation of Analytical Procedures:
6. Issa, C., Bansal, K., Gupta, P. ,. n.d. “Simultaneous Determination of Ketorolac Tromethamine and Furosemide in Intestinal Perfusion Samples by Validated Reversed Phase High-Performance Liquid Chromatography. Ind. J. Pharm. Science.” 2005 67(6):672–76.
7. Mali, Audumbar, Santosh Jadhav, Rahul Gorad, Aamer Quazi, Ritesh Bathe, Manojkumar Patil, and Ashpak Tamboli. 2016. “Simultaneous UV Spectrophotometric Methods for Estimation of Cefixime Trihydrate and Ofloxacin in Bulk and Tablet Dosage Form.” Asian Journal of Pharmaceutical Research 6(2):100. doi: 10.5958/2231-5691.2016.00017.4.
8. Mirza, B.A., Kugalur, G. P. ,. n.d. “Formulation and Evaluation of Ketorolac Ocular Ph-Triggered in-Situ Gel. Int. J. Drug. Dev & Res.” 2(2):379–87.
9. Muhammad, A., Ullah Khanand, I.I.M., Naeem R., S. ,. n.d. “Stability Indicating HPLC Method for Simultaneous Determination of Moxifloxacin Hydrochloride and Ketorolac Tromethamine in Pharmaceutical Formulations. Quim Nova.” 1(6):200–209.
10. Pavani A., P. L. K. M. Rao. n.d. “Revalidation and Analytical Evaluation of Ketorolac Tromethamine By Hptlc Using Reflectance Scanning Densitometry.” IJRPC 2011 1(2):129–32.
11. Razzaq, Syed Naeem, Islam Ullah Khan, Muhammad Ashfaq, and Irfana Mariam. 2012. “Stability Indicating HPLC Method for Simultaneous Determination of Moxifloxacin Hydrochloride and Ketorolac Tromethamine in Pharmaceutical Formulations.” Química Nova 35(6):1216–21. doi: 10.1590/S0100-40422012000600028.
12. Squella, J. A., I. Lemus, J. C. Sturm, and L. J. Núñez-Vergara. 1997. “Voltammetric Behaviour of Ketorolac and Its HPLC-EC Determination in Tablets.” Analytical Letters 30(3):553–64. doi: 10.1080/00032719708001801.
13. Sumit, C., Patil, A. B. ,. 2009. “Formulation and Evaluation of Mouth Dissolving Tabletof Ketorolac Tromethamine for Pain Management by Using Superdisintegrants.” International Journal of ChemTech ResearchVol.1(No.4):1008–13.
14. Sunil, G., M. Jambulingam, S. Ananda Thangadurai, D. Kamalakannan, R. Sundaraganapathy, and C. Jothimanivannan. 2017. “Development and Validation of Ketorolac Tromethamine in Eye Drop Formulation by RP-HPLC Method.” Arabian Journal of Chemistry 10:S928–35. doi: 10.1016/j.arabjc.2012.12.031.
15. Yang, Jeon-Heon, Mi-Young Yun, Dae-Keun Kim, Mi-Jeong Kim, Young-ll Kim, Tae-Youl Kim, Kyu-Ho Yang, and Sang-Chul Shin. 2007. “Preparation and Evaluation of Ketorolac Tromethamine Gel Containing Genipin for Periodontal Diseases.” Archives of Pharmacal Research 30(7):871–75. doi: 10.1007/BF02978839.
Statistics
31 Views | 25 Downloads
How to Cite
Dule, P., & Kilor, V. (2022). Development and Validation of RP-HPLC Method for Oral Printed Films of Ketorolac Tromethamine. Asian Journal of Pharmaceutical Research and Development, 10(5), 45-52. https://doi.org/https://doi.org/10.22270/ajprd.v10i5.1170