Volume : 09, Issue : 01, January – 2022
Title:
31.METHOD DEVELOPMENT AND VALIDATION OF PREGABALIN AND ETORICOXIB IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD
Authors :
Prakash M*, Abirami G.* and Vetrichelvan T.
Abstract :
A simple, accurate, precise and highly selective revers phase high performance liquid chromatography (RP-HPLC) method was developed and velaidated for pregabalin and etoricoxib. Chromatographic separation was achived isocratically by using Thermo scientific Accela Autosampler HPLC system, C8 column (250mm × 4.6 mm I, d.5μ). flow rate selected was 1ml/min. Detection wavelength 210 nm and sample volume 10µl , run time 10 min. the mobile phase employed was potassium dihydrogen orthophosphate buffer pH 6 – with Ortho phosphoric acid : Methanol : Acetonitrile (70:15:15 % V/V/V) which resulted best resolution and sensitivity. Developed method was validated in terms of linearity range (from 120-195 μg/ml of Pregabalin and 96-156 μg/ml of Etoricoxib) correlation coefficient was found for 0.9996 of PRE and 0.9998 ETO. The low RSD values indicate good precision and high recovery values indicate accuracy of the proposed method. The proposed method has been applied to the determination of drugs in commercial formulations. Assay results were in good agreement with label claim was found to be 99.56% and 100.16% of Pregabalin and Etoricoxib. The method was validated as per ICH guidelines. The developed method was simple, accurate, precise, specific, sensitive and reproducible which can be efficiently and easily applied to pharmaceutical dosage forms.
KEYWORDS: Pregabalin, Etoricoxib, HPLC, potassium dihydrogen orthophosphate buffer.
Cite This Article:
Please cite this article in press Abirami G et al, Method Development And Validation Of Pregabalin And Etoricoxib In Bulk And Pharmaceutical Dosage Form By RP-HPLC Method., Indo Am. J. P. Sci, 2022; 09(01).
Number of Downloads : 10
References:
1. Tripathi K D. ESSENTIALS OF MEDICAL PHARMACOLOGY. Jay Pee brothers medical publishers (P) Ltd. 2008; 6: 539-41.
2. Rang H, Dale M, Ritter JM and Moore PK. “Pharmacology”. 5th ed: Elsevier Publication, 2006; 298-300.
3. United States Pharmacopoeia Published by the United States Pharmacopeial convention Rockville MD US, 2012, USP38, 4370-4371.
4. The United State Pharmacopeia Asian edition; 2005. 1279-1281.
5. The United States Pharmacopeial Convention Revision Bulletin Official; 2012. 1-2.
6. Beckett AH, Stenlake JB. Practice Pharmaceutical Chemistry, 4ed. New Delhi: CBS Publisher; 1997. 285-288.
7. Santosh G.Shep, Lahoti.S.R ., Development and Validation of UV Spectrophotometric Method of Pregabain in Bulk and Pharmaceutical Formulation ., International Journal of Pharma Tech Research ., 5(3), 2013, 1264-1270.
8. Shahi.S.R , Agrawal.G.R , Rathi.P.B, Shinde.N.V, Somani.V.G ., Development and Validation of UV Spectrophotometric Method for the Determination of Etoricoxib in Bulk and Tablet Formulation ., Rasayan J. Chem ., 1(2), 2008 , 390-394.
9. Alka Bali and Pratee Kgaur., A Novel Method for Spectrophotometric Determination of Pregabalin in Pure Form and in Capsules. Chemistry Central Journal, 5(59), 2011, 1-7.
10. Rajinder Singh Gujral, Sk Manirul Haque , Sanjeev Kumar, A Novel Method for the Determination of Pregabalin in Bulk Pharmaceutical Formulation and Human Urine Samples., African Journal of Pharmacy and Pharmacology., 3(6),2009,327-334.
11. Raju Chandra, Ashwani Sanghi, Deepak Kumar, Krishna Kumar Hindwan., Develop A Simple RP-HPLC And UV-Visible Method for Estimation of Etoricoxib From Pharmaceutical Dosage., British Biomedical Bulletin., 2(4),2014,706-713.
12. Saeed Arayne.M, Hina Shahnaz, Amir Ali, Najma Sultana., Monitoring of Pregabalin in Pharmaceutical Formulation and Human Serum Using UV and RP-HPLC Techniques: Application to Dissolution Test Method., Pharmaceutica Analytica Acta ., 5(2), 2014, 1-7.
13. Farooqui.M.N. , Kasawar.G.B., Development And Validation of HPLC Method for the Determination of Pregabalin in Capsules., Indian Journal of Pharmaceutical Science., 72(4),2010, 517-519.
14. Gangane.P.S , Bagde.S.M , Mujbaile.S.G And Niranjane.K.D., Development And Validation of HPLC Assay Method for Etoricoxib in Bulk Drug and Tablet Formulation., Indian Journal of Natural Sciences., 4(24),2014,1565-1572.
15. Haritha Potluri, Sheenivasa Rao Battula, Sunandamma Yeturu., Validated Stability Indicating RP-HPLC Method for Simultaneous Determination of Nortriptyline and Pregabalin in Bulk and Combined Dosage Formulation., J.Chi.Chem.Soc., 62(2),2017,1-14.
16. Ashok Kumar.A , Bhavya.T , Anil Mohan.J , RP-HPLC Method Development and Validation for the Simultaneous Quantitative Estimation of Pregabalin and Alpha Lipoic Acid in Capsules. International Journal of Pharmacy and Pharmaceutical Sciences, 6 (1), 2014, 270- 277.
17. Srinivas.A , Soujanya GK , Agaiah Goud.B , Method Development and Validation for Simultaneous Estimation of Paracetamol and Etoricoxib in Bulk and Pharmaceutical Dosage Form By RP-HPLC., Journal of Advanced Pharmaceutical Sciences ., 4(1) , 2014 , 556-564.
18. Navin Goyal, Anil Bhandari, Suresh Jain, Rikesh Patel., Method Development and Validation of Etoricoxib and Thiocolchicoside in Combined Pharmaceutical Solid Dosage Form By RP-HPLC Method., International Journal of Pharmaceutical Studies and Research., 2(1).2011,106-109.
19. ICH Q2A Text on validation of analytical procedure, International conference on harmonization. Tripartite guideline, 1994; 1-5.
20. ICH Q2B Validation of analytical procedure: methodology, International conference of harmonization. Tripartite guideline, 1994; 1-10.