DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF THIOCOLCHICOSIDE AND DEXKETOPROFEN IN BULK AND TABLET DOSAGE FORM
Abstract
Development and validation of two simple, accurate, precise and economical UV Spectrophotometric methods for simultaneous estimation of Thiocolchicoside and Dexketoprofen in bulk and in tablet dosage form. The methods employed were Method-1 Absorbance correction method and Method-2 First order derivative spectroscopic method. In method-1 Absorbance is measured at two wavelengths 370nm at which Dexketoprofen has no absorbance and 255nm at which both the drug have considerable absorbance. In method-2, two wavelengths 232nm for Thiocolchicoside (zero cross for Dexketoprofen) and 242nm for Dexketoprofen (zero cross for Thiocolchicoside) were selected. The beers law obeyed in the concentration range 4-40µg/ml and 5-50µg/ml for Thiocolchicoside and Dexketoprofen respectively in methanol. The suggested method is validated by using ICH validation parameters like accuracy, precision, linearity, LOD and LOQ respectively. Recovery study values of Thiocolchicoside and Dexketoprofen was found 99.8% and 100.2% respectively for both the methods. Standard deviation and RSD for intra-day and inter-day precision studies was found to be less than ± 2. The linearity coefficient was found 0.9996 at 242nm and 0.999 at 255 nm for Dexketoprofen and 0.9997 at both 232nm and 370nm for Thiocolchicoside. The LOD and LOQ for Method-1 were found to be 0.0067μg/ml and 0.020μg/ml for Thiocolchicoside, 0.043μg/ml and 0.132μg/ml for Dexketoprofen and for Method-2 were found to be 0.0093μg/ml and 0.028μg/ml for Thiocolchicoside, 0.055μg/ml and 0.168μg/ml for Dexketoprofen respectively. The developed methods were successfully applied to estimate the amount of Thiocolchicoside and Dexketoprofen in bulk and tablet dosage form.
Keywords:
Thiocolchicoside, Dexketoprofen, Absorbance correction method, First order derivative spectroscopic methodDOI
https://doi.org/10.25004/IJPSDR.2012.040217References
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14. Sahoo M, Syal P, Ingale S, Ingale K, Sinde S, Sali M, Choudhari VP, Kuchekar BS. Development and validation of a RP-HPLC-PDA method for simultaneous determination of Lornoxicam and Thiocolchicoside in pharmaceutical dosage form and its application for dissolution study. Int. J. Res. Pharm. Sci. 2011; 2(1): 1-7.
15. Umarkar AR, Rewatkar NS, Charde MS, Charde RM, Kasture AV. RP-HPLC method development and validation for estimation of Thiocolchicoside and Diclofenac potassium in bulk and capsule dosage forms. J Pharm. Res. 2011; 4(5): 1307-1308.
16. Walash M, Belal F, Eid M, Abass S, Abo EI. Simultaneous HPLC determination of Thiocolchicoside and Glafenine as well as Thiocolchicoside and Floctafenine in their combined dosage forms. J Chromatographic Sci. 2011; 49: 159-164.
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18. Sahoo M, Syal P, Hable A, Raut RP, Ingale S, Choudhari VP, Kuchekar BS. Development and validation of HPTLC method for simultaneous estimation of lornoxicam and thiocolchicoside in combined dosage form. Pharma. Methods. 2011; 2 (3): 178-183.
19. Patil ST, Bhusari VK, Dhaneshwar SR. Validated HPTLC method for simultaneous estimation of thiocolchicoside and aceclofenac in bulk drug and formulation. Int. J of Pharma. Bio. Sci. 2011; 2 (2): 482-490.
20. Gandhi S, DeshpandeP, Sengar M. HPTLC determination diclofenac sodium and thiocolchicoside in fixed dose combination. Int. Res. J Pharm. 2010; 1 (1): 220-224.
21. Ragehy NA, Ellaithy MM, Ghobashy MA. Determination of thiocolchicoside in its binary mixtures (thiocolchicoside-/glafenine and thiocolchicoside-/floctafenine) by TLC densitometry. IlFarmaco. 2003; 58: 463-468.
22. Del GE, Aprile S, Grosa G. Forced degradation study of thiocolchicoside: Characterization of its degradation products. J Pharma. Biomed. Ana. 2012; 61: 215– 223.
23. Kothapalli LP, Karape AK, Thomas AB, Nanda RK, Gaidhani P, Choudhari ME. Simultaneous spectrophotometric estimation of Paracetamol and Dexketoprofen trometamol in pharmaceutical dosage form. Scholars Res Lib., Der Pharmacia Lettre. 2011; 3(1): 365-371.
24. Pandya K, Mehta D, Patel K, Patel J, Shah N. Development and validation of UV spectroscopic and RP-HPLC methods for estimation of Dexketoprofen trometamol in tablet dosage form. J of Pharma. Sci. and Bioscientific Res. 2011; 1(1): 78-85.
25. Mulla TS, Rao JR, Yadav SS, Bharekar VV, Rajput MP. Development and validation of HPLC method for simultaneous quantitation of paracetamol and Dexketoprofen trometamol in bulk drug and formulation. Int. J of Comprehensive Pharm. 2011; 7 (09): 1-4.
26. Rao JR, Mulla TS, Bharekar VV, Yadav SS, Rajput MP. Simultaneous HPTLC Determination of Paracetamol and Dexketoprofen trometamol in pharmaceutical dosage form. Scholars Res. Lib., Der Pharma Chemica. 2011; 3(3): 32-38.
27. ICH, Q2 (R1), Harmonised tripartite guideline, Validation of analytical procedures: text and methodology International Conference on Harmonization ICH, Geneva, Nov 2005.
2. Maryadele JO, Heckelman PE, Koch CB, Roman KJ. Editors. The Merck Index: an Encyclopedia of Chemicals, Drugs and Biologicals. Edn14, Merck Research Lab, Division of Merck and co. Inc., Whitehouse Station, NJ, USA, 2006, pp. 918.
3. Wankhede SB, Zambare SS, Chitlange SS. Estimation of Thiocolchicoside and Ketoprofen in pharmaceutical dosage form by Spectrophotometric methods. J Pharm. Res. 2010; 3(4):707-710.
4. Nikhade RD, Thakur AD, Choudhari SB, Chandewar AV. Simultaneous Estimation of Paracetamol, Thiocolchicoside and Aceclofenac by UV Spectrophotometer using multicomponent mode method. J Pharm. Res. 2011; 4(7): 2297-2299.
5. Joshi RR, Gupta KR. Simultaneous UV-Spectrophotometric determination of Thiocolchicoside and Diclofenac in Pharmaceutical formulation. Pelagia Res. Lib.; Der Pharmacia Sinica. 2010; 1 (2): 44-51.
6. Acharjya SK, Rajesh Y, Panda P, Mallick P, Annapurna MM. Spectrophotometric methods for simultaneous estimation of etoricoxib and thiocolchicoside in bulk and combined pharmaceutical dosage form. J Pharm. Educ. Res. 2010; 1(1): 75-82.
7. Acharjya SK, Rajesh Y, Panda P, Mallick P, Annapurna MM. Spectrophotometric methods for the determination of thiocolchicoside in bulk and pharmaceutical dosage forms. J Pharm. Educ. Res. 2010; 1(1): 51-57.
8. Choudhari VP, Chabukswar AR, Tryambake MU, Savakhande SN. Spectrophotometric simultaneous determination of diclofenac potassium B.P. and thiocolchicoside in combined tablet dosage form by absorption correction method and area under curve method. Int. J Pharm. Sci. Rev. and Res. 2011; 7(2): 182-185.
9. Umarkar AR, Rewatkar NS, Charde MS, Charde RM. Simultaneous estimation of Thiocolchicoside and Diclofenac Potassium by UV spectrophotometer using multicomponent method. Int. J of Chem.Tech. Res. 2011; 3(2): 944-947.
10. Sengar MR, Gandhi SV, Patil UP, Rajmane VS. Simultaneous determination of diclofenac sodium and thiocolchicoside in fixed dose combination by spectrophotometry. Asian J of Pharm. and Clinical Res. 2010; 3(2): 89-91.
11. Chitlange SS, Shinde PS, Pawbake GR, Wankhede SB. Simultaneous estimation of Thiocolchicoside and Aceclofenac in pharmaceutical dosage form by spectrophotometric and LC method. Scholars Res. Lib., Der Pharmacia Lettre. 2010; 2(2): 86-93.
12. Wankhede SB, Zambare SS, Dixit NR, Chitlange SS. RP-HPLC Method for Simultaneous estimation of Thiocolchicoside and Ketoprofen in combined dosage form. Scholars Res. Lib., Der Pharmacia Lettre. 2010; 2(3): 315-320.
13. Kumar S, Joshi A, Thakur RS, Pathak AK, Shah K. Simultaneous estimation of etoricoxib and thiocolchicoside by RP-HPLC method in combined dosage forms. Acta Poloniae Pharmaceutica - Drug Res. 2011; 68(6): 839-845.
14. Sahoo M, Syal P, Ingale S, Ingale K, Sinde S, Sali M, Choudhari VP, Kuchekar BS. Development and validation of a RP-HPLC-PDA method for simultaneous determination of Lornoxicam and Thiocolchicoside in pharmaceutical dosage form and its application for dissolution study. Int. J. Res. Pharm. Sci. 2011; 2(1): 1-7.
15. Umarkar AR, Rewatkar NS, Charde MS, Charde RM, Kasture AV. RP-HPLC method development and validation for estimation of Thiocolchicoside and Diclofenac potassium in bulk and capsule dosage forms. J Pharm. Res. 2011; 4(5): 1307-1308.
16. Walash M, Belal F, Eid M, Abass S, Abo EI. Simultaneous HPLC determination of Thiocolchicoside and Glafenine as well as Thiocolchicoside and Floctafenine in their combined dosage forms. J Chromatographic Sci. 2011; 49: 159-164.
17. Jadhav SD, Butle SR, Patil SD, Jagtap PK. Validated stability indicating RP-HPLC method for simultaneous determination and in-vitro dissolution studies of thiocolchicoside and diclofenac potassium from tablet dosage form. Arabian J of Chem. 2011; 1-11.
18. Sahoo M, Syal P, Hable A, Raut RP, Ingale S, Choudhari VP, Kuchekar BS. Development and validation of HPTLC method for simultaneous estimation of lornoxicam and thiocolchicoside in combined dosage form. Pharma. Methods. 2011; 2 (3): 178-183.
19. Patil ST, Bhusari VK, Dhaneshwar SR. Validated HPTLC method for simultaneous estimation of thiocolchicoside and aceclofenac in bulk drug and formulation. Int. J of Pharma. Bio. Sci. 2011; 2 (2): 482-490.
20. Gandhi S, DeshpandeP, Sengar M. HPTLC determination diclofenac sodium and thiocolchicoside in fixed dose combination. Int. Res. J Pharm. 2010; 1 (1): 220-224.
21. Ragehy NA, Ellaithy MM, Ghobashy MA. Determination of thiocolchicoside in its binary mixtures (thiocolchicoside-/glafenine and thiocolchicoside-/floctafenine) by TLC densitometry. IlFarmaco. 2003; 58: 463-468.
22. Del GE, Aprile S, Grosa G. Forced degradation study of thiocolchicoside: Characterization of its degradation products. J Pharma. Biomed. Ana. 2012; 61: 215– 223.
23. Kothapalli LP, Karape AK, Thomas AB, Nanda RK, Gaidhani P, Choudhari ME. Simultaneous spectrophotometric estimation of Paracetamol and Dexketoprofen trometamol in pharmaceutical dosage form. Scholars Res Lib., Der Pharmacia Lettre. 2011; 3(1): 365-371.
24. Pandya K, Mehta D, Patel K, Patel J, Shah N. Development and validation of UV spectroscopic and RP-HPLC methods for estimation of Dexketoprofen trometamol in tablet dosage form. J of Pharma. Sci. and Bioscientific Res. 2011; 1(1): 78-85.
25. Mulla TS, Rao JR, Yadav SS, Bharekar VV, Rajput MP. Development and validation of HPLC method for simultaneous quantitation of paracetamol and Dexketoprofen trometamol in bulk drug and formulation. Int. J of Comprehensive Pharm. 2011; 7 (09): 1-4.
26. Rao JR, Mulla TS, Bharekar VV, Yadav SS, Rajput MP. Simultaneous HPTLC Determination of Paracetamol and Dexketoprofen trometamol in pharmaceutical dosage form. Scholars Res. Lib., Der Pharma Chemica. 2011; 3(3): 32-38.
27. ICH, Q2 (R1), Harmonised tripartite guideline, Validation of analytical procedures: text and methodology International Conference on Harmonization ICH, Geneva, Nov 2005.
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01-04-2012
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“DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF THIOCOLCHICOSIDE AND DEXKETOPROFEN IN BULK AND TABLET DOSAGE FORM”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 4, no. 2, Apr. 2012, pp. 160-3, https://doi.org/10.25004/IJPSDR.2012.040217.
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How to Cite
“DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF THIOCOLCHICOSIDE AND DEXKETOPROFEN IN BULK AND TABLET DOSAGE FORM”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 4, no. 2, Apr. 2012, pp. 160-3, https://doi.org/10.25004/IJPSDR.2012.040217.
