Validated Stability Indicating HPTLC of Aceclofenac

Authors

  • Dr. D. S. Ghotekar  Department of Chemistry, N.V.P.Mandal’s, Arts, Commerce and Science College Lasalgaon Tal-Niphad, Dist-Nashik, Maharashtra, India
  • Suvarna A Wagh  Department of Pharmaceutical chemistry, Maratha Vidya Prasarak Samaja’s Institute of Pharmaceutical Sciences„ Adgaon, Nashik, Maharashtra, India.
  • Pritishchandra S Kabra  Department of Pharmaceutics, DJPS College of pharmacy, pohetakli, Tal. pathri, Dist Parbhani, Maharashtra, India

Keywords:

Aceclofenac, validation, HPTLC

Abstract

The present paper describes stability indicating high-performance thin-layer chromatography (HPTLC) assay method for Aceclofenac in bulk drugs. The method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of toluene: methanol: triethylamine (6.5: 4.0: 0.1 v/v/v). The system was found to give compact spot for Aceclofenac (Rfvalue of 0.64 ? 0.028). Densitometric analysis of Aceclofenac was carried out in the absorbance mode at 243 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.999 with respect to peak area in the concentration range 30 - 120 ng/spot. The developed HPTLC method was validated with respect to accuracy, precision, recovery and robustness. Also to determine related substance and assay determination of Aceclofenac that can be used to evaluate the quality of regular production samples. The developed method can also be conveniently used for the assay determination of Aceclofenac. The limits of detection and quantitation were 4.062 and 12.322 ng/spot, respectively by height.

References

  1. Sethi, P. D., In HPTLC- Quantitative Analysis of Pharmaceutical Formulations, CBS Publisher and Distributor, New Delhi, ІInd ed., 1996, p. 1-19.
  2. D.H. Shewiyoa,b,c, E. Kaaleb, P.G. Rishab, B. Dejaegherc, J. Smeyers-Verbekec, Y. Vander Heyden. HPTLC methods to assay active ingredients in pharmaceutical formulations: A review of the method development and validation steps. Journal of Pharmaceutical and Biomedical Analysis, 2012, 66, p. 11– 23.
  3. Nadig, D. E., "Preparation of drug sample for Analysis", Handbook of Pharmaceutical Analysis; Ohannesian, L., New Jersey, 2002; p. 1-3.
  4. Sonia K, Beddi Bhavya shree, Dr.K.S.Lakshmi, "HPTLC Method Development and Validation: An Overview", J. Pharm. Sci. & Res. Vol. 9(5), 2017, 652-657
  5. Vishal N Kushare, Sagar V Ghotekar. Development of a Validated Stability Indicating RP- HPLC Method for Assay of Ozagrel and Its Pharmaceutical Formulations, International Journal of Pharmacy and Pharmaceutical Research. January 2019 Vol.: 14, Issue: 2.pg.no 46 to 65
  6. Vishal N Kushare, Sachin S Kushare, Development of Validated Stability Indicating HPTLC Method for Assay of Ozagrel and its Pharmaceutical Formulations, International Journal of Scientific Research in Science, Engineering and Technology. November- December-2018 [4 (11): 36 to 48]
  7. Vishal N Kushare, Sachin S. Kushare, Sagar V Ghotekar Development of Validated UV Spectrophotometric Method for Assay of Ozagrel and its Pharmaceutical Formulations. International Journal of Scientific Research in Science, Engineering and Technology. November-December-2018 [4 (11): 69 to 77]
  8. Vishal N. Kushare, Sagar V. Ghotekar, Morade V.B, Salade J. N, Preparation of Transdermal Patch and Evaluation of Physical Parameters, International Journal of Scientific Research in Science, Engineering and Technology.January-February-2019 [6 (1): 01 to 04]
  9. Vishal N. Kushare, Pritishchandra S.Kabra, Overview to Drug Development Process International Journal of Scientific Research in Science, Engineering and Technology. September-October-2019 [6 (5): 70 to 73]
  10. Dr.D.S.Ghotekar, Vishal N. Kushare, Validated Stability Indicating HPTLC of Clopidogrel and its Pharmaceutical Formulations. International Journal of Scientific Research in Science, Engineering and Technology.January-February-2019 [6 (1): 557 to 567]
  11. Dr.D.S.Ghotekar, Vishal N. Kushare, Assay of Clopidogrel by Using HPLTC Method. Journal of Scientific Research in Science and Technology. (www.ijsrst.com) November- December-2018 [4 (11): 557 to 561]
  12. Dr.D.S.Ghotekar, Vishal N. Kushare, Preparation and Characterization of Atenolol Base from Hydrochloric Salt. Our Heritage, Vol-68-Issue-1-January -2020, Page no. 11102 to 11107.
  13. Dr.D.S.Ghotekar, Vishal N Kushare, Ultrasound Promoted Synthesis and Characterization of Some Chalcones, Chromones and 1, 5 Benzothiazepines as Antibacterial and Antifungal Agent, Our Heritage, Vol-68-Issue-1-January -2020, Page No.11117 to 11124.
  14. Dr.D.S.Ghotekar, Vishal N. Kushare, 'Development of a Validated Stability Indicating RP-HPLC Method for Assay of Clopidogrel', Journal of Scientific Research in Science And Technology. (www.ijsrst.com) March-April-2019. [6 (2):834 to 838]
  15. Vishal N Kushare, Sagar V Ghotekar. Principles of analytical chemistry to drug Analysis & Stability Indicating Assay Method (SIAM), International Journal of Scientific Research in Chemistry (www.ijsrch.com). July-August- 2020. Vol.5, Issue: 4. pg.no.24 To 28
  16. Dr.D.S.Ghotekar, Vishal N. Kushare, 'Validated Stability Indicating HPTLC of Paracetamol’. Journal of Scientific Research in Science and Technology. (www.ijsrst.com) November-December-2017 [3 (4): 581 to 586]

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Published

2022-06-30

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Section

Research Articles

How to Cite

[1]
Dr. D. S. Ghotekar, Suvarna A Wagh, Pritishchandra S Kabra, " Validated Stability Indicating HPTLC of Aceclofenac, International Journal of Scientific Research in Science, Engineering and Technology(IJSRSET), Print ISSN : 2395-1990, Online ISSN : 2394-4099, Volume 9, Issue 3, pp.441-447, May-June-2022.