Application of Ratio Derivative Spectrophotometry for Simultaneous Determination of Clonazepam and Paroxetine Hydrochloride in Tablet Dosage Form


Application of Ratio Derivative Spectrophotometry for Simultaneous Determination of Clonazepam and Paroxetine Hydrochloride in Tablet Dosage Form


Jalpa U. Patel*1, Himani Dalwadi2 ,Dr. Purvi Shah3

1Indukaka Ipcowala College of Pharmacy, Beyond GIDC, P.B. No. 53, Vitthal Udyognagar 388 121, Gujarat, India.
2Indukaka Ipcowala College of Pharmacy, Beyond GIDC, P.B. No. 53, Vitthal Udyognagar 388 121, Gujarat, India.
3Anand Pharmacy College,Near town hall,Anand-388001


Journal of Pharmaceutical Research and Reviews

Ratio derivative spectrophotometric method has been developed for the simultaneous estimation of Clonazepam and Paroxetine hydrochloride in pharmaceutical dosage form. In this method, the overlapping spectra of Clonazepam and Paroxetine hydrochloride were well resolved by making use of the first-derivative of the ratios of their direct absorption spectra. The derivative ratio absorbance of Clonazepam and Paroxetine hydrochloride were measured at 312.28 nm and 304.88 nm, respectively for their quantification. Clonazepam and Paroxetine hydrochloride were determined in the concentration range of 5-30 µg/ml and 10-60 µg/ml respectively. The linear regression analysis for the calibration plots produced r2= 0.9956 and r2= 0.9994 for Clonazepam and Paroxetine hydrochloride respectively. The precision, accuracy, limit of detection and limit of quantitation of the method were validated according to the ICH guidelines. The results indicate that the method is suitable for the routine quality control testing of marketed tablet formulations.


Keywords: Simultaneous determination, Clonazepam, Paroxetine hydrochloride, Ratio derivative spectrophotometric method

Free Full-text PDF


How to cite this article:
Jalpa U. Patel, Himani Dalwadi, Purvi Shah.Application of Ratio Derivative Spectrophotometry for Simultaneous Determination of Clonazepam and Paroxetine Hydrochloride in Tablet Dosage Form. Journal of Pharmaceutical Research and Reviews, 2018; 2:8.


References:

1. Indian Pharmacopoeia, Ministry of Health and Family Welfare. vol. 2, Indian Pharmacopoeial Commission, Ghaziabad, 2014; 1434, 2439.
2. Rang HP, Dale M.M, Ritter JM, Flower R.J. Rang and Dale’s Pharmacology. Churchill Livingstone Elsevier. 2007; 6th Ed: 536–542.
3. Brown JH, Taylor P, Robert LJ, Marrow. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. McGraw-Hill, New York, 2001: 280.
4. Sharma MC, Sharma S. Validated. Simultaneous spectrophotometric estimation of Paroxetine HCl bulk and tablet dosage form using Ferric Chloride. J. of Optoelectro. and Biomed. Materials, 2010; 2(4):185–189.
5. Jagawat T. A. Comparative study to assess the efficacy and safety of combination capsules of paroxetine and clonazepam in comparison to paroxetine in patients suffering from co morbid depression and anxiety. Delhi Psy J, 2011; 14:106–109.
6. American Psychiatry Association. Diagnostic and Statistical Manual of Mental Disorders Ed (DSM-IV), APA, Washington, DC, 1994.
7. United States Pharmacopeia 38, National Formulary 33, vol. 2, The United States Pharmacopoeial Convention, Rockville. 2015; 2888, 4765.
8. British Pharmacopoeia, Medicines and Health Care Products Regulatory Agency, vols. 1 and 2, London. 2014; 506–508,587–588.
9. Onal A, Kepekci S, Oztunc A. Spectrophotometric methods for the determination of the antidepressant drug Paroxetine hydrochloride in tablets. J of AOAC Int, 2005; 88(2):490–495.
10. Kakde RB, Satone DD. Spectrophotometric method for simultaneous estimation of escitalopram oxalate and clonazepam in tablet dosage form. Indian J of Pharm Sci, 2009; 71(6):702–705.
11. Syed MR, Hasmi S, Naik JB. UV spectrophotometric method development and validation for determination of Paroxetine hydrochloride in pharmaceutical dosage form. International J of Pharm Sci, 2010; 2(2):43–45.
12. Sharma MC, Sharma S. Validated simultaneous spectrophotometric estimation of paroxetine HCl bulk and tablet dosage form using ferric chloride. J of Optoele and Bio Materials, 2010; 2(4):185-189.
13. Patel VB, Dave JB, Patel FM, Patel CN. UV spectrophotometric method for identification and estimation of clonazepam in tablet dosage form. Inter J of Pharm Res and Bio-sci, 2012;1:62–70.
14. Naval A, Sawsan A, Maha S. Spectroflourimetric determination of Paroxetine Hydrochloride in its formulation and human plasma. Chem and Pharm Bull, 2006; 54(4):564–566.
15. Darwish IA, Amer SM, Abdine H, Al-Rayes LI. New spectrofluorimetric method with enhanced sensitivity for determination of paroxetine in dosage forms and plasma. Ana Chem Insights, 2008; 3:145–155.
16. Christopher J, Stewart TJ. Analysis of clonazepam in a tablet dosage form using small bore HPLC. J of Pharm and Bio Ana, 1998; 18(3):453–460.
17. Lambropoulos J, Spanos GA, Lazaridis NV. Method development and validation for the HPLC assay (potency and related substances) for 20 mg paroxetine tablets. J of Pharm and Bio Ana, 1999; 19(5):793–802.
18. Gandhi SV, Dhavale ND, Jadhav VY, Sabnis SS. Spectrophotometric and reversed-phase high-performance liquid chromatographic methods for simultaneous determination of escitalopram and clonazepam in combined tablet dosage form. J of AOAC Inter, 2008; 91(1):33–38.
19. Lakshmi SM, Kumaraswamy G, Ashwini GL. A validated RP-HPLC method for the estimation of paroxetine hydrochloride in bulk and tablet dosage form. J of Pharm Research, 2012; 5:1768.
20. Meghana DK, Lahari K, Shantha Kumari K, Prakash. Development and validation of RP-HPLC method for simultaneous estimation of clonazepam and propranolol hydrochloride in bulk and pharmaceutical dosage forms. Inventi Rapid: Pharm. Anal.QA, 2012; 4:1–5.
21. Chusena NB, Garikapati DR., Usha P. Development and validation of an RP-HPLC method for the simultaneous determination of Escitalopram Oxalate and Clonazepam in bulk and its pharmaceutical formulations. Inter Current Pharm J, 2012;1(8):193–198.
22. Tanikella SA, Sakinala S, Sundari CBT, Vaidya J. Development and validation of a RP-HPLC method for simultaneous estimation of propranolol HCl and clonazepam in bulk and pharmaceutical dosage forms. Inter Research J of Pharm, 2012; 3.
23. Chakole RD, Charde MS, Bhavsar N, Marathe RP. Simultaneous estimation of escitalopram and clonazepam by RP-HPLC in pharmaceutical formulations. Inter J of Phytopharm, 2012; 2(1):25–29.
24. Mallikarjuna R, Agarwal NK, Bichala PK, Som S. Method development and validation for the simultaneous estimation of Desvenlafaxine and Clonazepam in bulk and tablet formulation by RP-HPLC method, Indian J of Research and Pharm Biotech, 2013; 1:525–532.
25. Kakde RB, Satone DD, Gadapayale KK, Kakde MG. Stability-indicating RP-HPLC method for the simultaneous determination of escitalopram oxalate and Clonazepam. J of Chrom Sci. 2013; 51(6):490–495.
26. Agrawal N, Esteve-Romero J, Dubey NP, Durgbanshi A, Bose D, PerisVicente J, Carda-Broch S. Determination of paroxetine in pharmaceutical preparations using HPLC with electrochemical detection. Open Ana Chem J, 2013; 7:1–5.
27. Skibinski R, Misztal G, Kudrzycki M. Determination of fluoxetine and paroxetine in pharmaceutical formulations by densitometric and video densitometric TLC. J. of Planar Chrom -Modern TLC, 2003; 16(1):19–22.
28. Venkatachalam A, Chatterjee VS. Stability indicating high performance thin layer chromatography determination of Paroxetine hydrochloride in bulk drug and pharmaceutical formulations, Analytica Chimica Acta. 2007; 598(2):312–317.
29. Dhavale N, Gandhi S, Sabnis S, Bothara K. Simultaneous HPTLC determination of escitalopram and clonazepam in combined tablets. Chromatographia, 2008; 67(5):487-490.
30. Kakde R, Satone D, Bawane N. HPTLC method for simultaneous analysis of escitalopram and clonazepam in pharmaceutical preparation. J of Planar Chrom-Modern TLC, 2009; 22(6):417–420.
31. Boda JM, Bhalodiya HA, Patel PB. UV spectroscopic method for simultaneous estimation of clonazepam and Paroxetine hydrochloride hemihydrate in combined pharmaceutical formulation. Inventi Rapid: Pharm Ana and QA, 2012.
32. Sheeja VK, Swapna AS, Eapen SC, Kumar P. Method development and validation for the simultaneous estimation of clonazepam and paroxetine in combined dosage form using colorimetry. Asian J of Research in Chem, 2014; 7:48.
33. Yanamadala G, Praveen Srikumar PP. (). Development and validation of a stability-indicating HPLC method for the simultaneous determination of paroxetine hydrochloride and clonazepam in pharmaceutical dosage forms. Inter J of Pharm, 2014; 4(1):448–457.
34. Srinivas Reddy G, Prasad Reddy SLN, Shiva Kumar Reddy L. Development and validation of a stability indicating liquid chromatographic method for the simultaneous estimation of paroxetine and clonazepam in bulk and its pharmaceutical formulations. Inter J of Pharm and Pharm Sci, 2014; 6(10):397–402.
35. Shah P, Patel J, Patel K, Gandhi T. Development and validation of an HPTLC method for the simultaneous estimation of Clonazepam and Paroxetine hydrochloride using a DOE approach. J of Taibah Uni for Sci, 2016.
36. Umadurai M and Nagarajan V. Development and validation of a rapid UPLC Assay method for the simultaneous estimation of paroxetine and clonazepam in tablet dosage form. Inter J of Chem and Pharm Sci, 2014; 5(4).
37. International Conference on Harmonization, ICH Q2 (R1): Validation of Analytical Procedures: Text and Methodology. ICH Secretariat, Geneva, 2005.