DEVELOPMENT, VALIDATION & STRESS DEGRADATION STUDIES OF TRIPROLIDINE BY REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHGY (RP-HPLC)
Keywords:
Triprolidine; HPLC, Stress DegradationAbstract
To develop a simple, selective and precise and rapid reverse phase high performance liquid chromatography method for the development and validation, stress degradation studies of Troprolidine in bulk and Pharmaceutical dosage forms.
Methods: The chromatographic separations was performed by Agilent Polaris C18 column (150 X 4.6 mm id, ODS 2,5µ m) using methanol: 0.1% ortho-phosphoric acid in water (65:35) as mobile phase at flow rate of 0.1 mL/min with injection volume 20 µL and the detection was carried out using UV detector at 232nm. The method was validated as per ICH guidelines.
Results: The retention time for Troprolidine was found to be 1.88 min respectively . The linear regression analysis data for the calibration plots showed good linear relationship in the concentration range of 1.01-10.05µg/mL. The correlation coefficient and percent recovery for Troprolidine were found to be 0.9989 and 100.66 respectively. The influence of Acid, Alkaline, Oxidative stress, Photolytic stress condition on Troprolidine was studied. Results indicated completed degradation in Alkaline medium.
Conclusion: The developed method was successfully validated in accordance to ICH guidelines. This method is simple, selective, linear and precise accurate and sensitive and can be used for routine analysis of bulk samples.
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References
Drug Profile, "Triprolidine" http://www.mims.com/Troprolidine
Reynolds, J.E.F. 1982. Promethazine and other anti-histamines. In: Martindale: The Extra Pharmacopoeia, 28th Edition, pp.1294. The Pharmaceutical press, London.
R.L. Deangelis, M.F. Kearney and R. M. Welch. (1997). Determination of troprolidine in human plasma by quantitative TLC. Journal of Pharmaceutical Sciences.66 (6), 841-843.
Arvind Gupta, Rajesh Kumar Nema, Atul sahu. (2009). Simultaneous estimation of Phenylpropanolamine hydrochloride and Triprolidine hydrochloride in pharmaceutical preparations by RP-HPLC method. The Pharma Research.1;67-71.
Hetice Caglar, Ebru Buyuktuncel.(2014). HPLC method dvelopment and validation: Simultaneous determination of active ingredients in cough and cold Pharmacueticala. International journal of pharmacy and pharmaceutical sciences. 6(10), 421-428.
Yasser EL-Shabrawy, Alaa El-Gindy, Maisra Al-Shabraw Shoeib and Yassmin El-Gindy. (2014). An HPLC method for Determination of 15 Pharmaceutical compounds in Anti-cold Products. Standard Research Journal of Pharmacy and Pharmacology. 1(4), 86-94.
Alaa El-Gindya, Khalid Abdel-Salam Attiab, Mohammad Wafaa N assarb, Hamed Abu Aeadab and Maisra Al-Shabrawi Shoeibc. (2013). HPLC method for determination of Paracetamol, Psudoephedrine, Triprolidine, Methylparaben, Propylparaben, Sodium Benzoate and other related substances in Pharmaceutical syrup. Journal of liquid cheomatography & related technologies. 36(9), 1251-1263.
Basel M. Saida, Shrhabeel A.Alabjaw, Fawaz Deabas, Munib M. Saket, Rami Shareiah and Eyad S. M.Abu Nameh. (2014). Liquid chromatographic Method for the Determination of Triprolidine. Journal of chemical and Pharmaceutical Research, 6(8), 327-332.
Amina Mumtaz, Asrar A.Kazi, Tehseen Aman, M. Usman Sabri and Fauzia Noureen. (2005). Dtermination of Troprolidine-Hcl by Spectrophotometric method in pure and pharmaceutical preparartions using Dichloronitrobenzene as a new cheomagenic reagent. Proc.Pakistan Acad.Sci. 42(4), 253-259.
Madhuri Hinge, K.R.Patel and R.J.Mahinda. (2015). Spectrophotometrioc and High performance liquid chromatographic determination (HPLC) of Triprolidine and Pseudoephedrine hydrochloride in Tablet dosage form. Pharm Method. 15(6), 87-93.
Hansen EBJr, Getek TA, Korfmacher WA. (1989). Application of HPLC-Thermospray ionization mass spectrometry for the analysis of Triprolidine and its metabolite hydromethytriprolidine in biological samples. J Anal Toxicol. 13(3), 185-187.
Sonia Di Berardino, Renata Jasionowska. (2014). Rapid and sensitive CZE (capillary zone electrophoresis) method for Quality Control analysis of Pharmaceuticals containing Pseudoephedrine, Triprolidine and Paracetamol. American Journal of Analytical Chemistry.5;613-619.
Mahesh Kumar Moneab, K.B. Chandrasekh & Samir Vyasa. (2011). Degradation studies of Troprolidine: Isolation, Characterization of oxidative Degradationproducts and Development of a validated stability indicating indicating method UPLC method. Journal of Chromatography & Related Technologies. 34(8), 652-669.
Zayed, S.I. 2004. New plastic membrane and carbon paste ion selective electrodes for the determination of Troprolidine. Anal. Sci. 20:1043-1048.
C E Bye, J Cooper, D W Empey, A S Fowle, D T Hughes, E Letley, and J O'Grady (1980? Effects of pseudoephedrine and triprolidine, alone and in combination, on symptoms of the common cold.Br Med J. 1980 Jul 19; 281(6234): 189–190.
Guidance for Industry: Analytical Procedure and methods Validation: Chemistry, Manufacturing and Controls Documentation; Draft Guidance. Rockville, MD. UD FDA. 2000,
International Conference on Hormonization, "Q2A: Text on Validation of Analytical Procedures," Federal Register, 60(40), 1995, 11260-11262.
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