Simultaneous Analysis of Phenylephrine HCl and Ketorolac Tromethamine in Bulk and Injectable Formulations by RP-HPLC-PDA Method

  • PJ Nagarjuna Department of Pharmaceutics and Biotechnology, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, AP, INDIA
  • B Tharun Kumar Department of Pharmaceutics and Biotechnology, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, AP, INDIA
  • Buchi N. Nalluri Siddhartha Pharma Innovation and Incubation Center at KVSR Siddhartha college of Pharmaceutical Sciences, Vijayawada-520010, AP, INDIA

Abstract

Rapid, isocratic and economical RP-HPLC-PDA method was developed for the simultaneous estimation of Phenylephrine HCl (PEH) and Ketorolac Tromethamine (KTR) in bulk and injectable dosage forms. Chromatographic separation was achieved with the Agilent Eclipse C18 column (150×4.6mm;5µ) and the mobile phase composed of methanol and 2mM Ammonium acetate in the ratio 43:57v/v at a flow rate of 1mL/min. The injection volume was 5µL and eluents were monitored at 220nm. Response was a linear function of concentration in the range 30–105 μg/mL for Phenylephrine HCl (PEH) and 10–35 μg/mL Ketorolac Tromethamine (KTR); the correlation coefficients were 0.999 and 0.999, respectively.  The method was validated and is suitable for the simultaneous estimation of PEH and KTR in bulk and injectable dosage forms.


Keywords: Ketorolac tromethamine, Phenylephrine HCl, Reverse phase HPLC, PDA detector.

Keywords: Ketorolac tromethamine, Phenylephrine HCl, Reverse phase HPLC, PDA detector

Downloads

Download data is not yet available.

Author Biographies

PJ Nagarjuna, Department of Pharmaceutics and Biotechnology, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, AP, INDIA

Department of Pharmaceutics and Biotechnology, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, AP, INDIA

B Tharun Kumar, Department of Pharmaceutics and Biotechnology, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, AP, INDIA

Department of Pharmaceutics and Biotechnology, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada-520010, AP, INDIA

Buchi N. Nalluri, Siddhartha Pharma Innovation and Incubation Center at KVSR Siddhartha college of Pharmaceutical Sciences, Vijayawada-520010, AP, INDIA

Siddhartha Pharma Innovation and Incubation Center at KVSR Siddhartha college of Pharmaceutical Sciences, Vijayawada-520010, AP, INDIA

References

[1] Tripaty K.D., Essentials Of Pharmacology, 6th ed.; JAYPEE Brothers Medical Publishers (P) Ltd; 2006.P. 120-129, 184,194,200.
[2] The Indian Pharmacopoeia, 6th ed.; The Indian Pharmacopoeia Commission: Ghaziabad; 2010.P.1543, 1899.
[3] Rang, H. P, Dale M. M., Ritter J. M., Flower R. J, Henderson,G. Rang and Dale’s pharmacology, 7th ed.; Churchill Livingstone: London, 2012.P. 319t,11-13,128,429.
[4] Bertram G. Katang, Susan B. Masters, Anthony J Trevor, Basic and clinical Pharmacology, 12th ed.; Tata Mc GRAW-HILL: 2012, P. 133t, 136f,141,148,642.
[5] Balan P, Kannappan N, Bhimadhuni CNR, Simultaneous estimation of Olopatadine Hydrochloride and Ketorolac Tromethamine in bulk and pharmaceutical dosage forms by RP-HPLC method. Int journal of research in pharmaceutical sciences, 2014; 5(1):14-19.
[6] Prathap B, Dey A. Rao G, Analytical method development and validation for simultaneous estimation of Febuxostat and Ketorolac in bulk and pharmaceutical dosage form in rat plasma by RP-HPLC. IAJPR, 2014; 4(4):1729-77.
[7] Dubey, S. K, Duddelly. S, Jangala. H., Saha R. N, Rapid and sensitive reverse phase high performance liquid chromatography methods for estimation of Ketorolac in pharmaceutical dosage forms, Indian J. Pharm Sci, 2013; 75(1):89-93.
[8] Rahul S, Ashish P, Pooja C. Method development and validation for simultaneous estimation of Ketorolac and Sparfloxocin by RP- HPLC. Indian Journal of Pharmaceutical and Biological Research, 2013; 1(4):95-101.
[9] Syed NR, Ashfaq M, Ullah Khan I, Irfana M. Stability indicating HPLC method for simultaneous determination of ofloxocin and ketorolac tromethamine in pharmaceutical formulation. Analytical methods, 2012; 4(7):2121-26.
[10] Boyka GT, Ivanka PP, Plamen TP, HPLC determination of Ketorolac tromethamine in tablet dosage forms. Der Pharmacia Sinica. 2012; 3(4): 400.
[11] Dharti P, Mehul P, Ketan P. Simultaneous RP-HPLC estimation of Moxifloxacin hydrochloride and Ketorolac tromethamine in ophthalmic dosage forms. Asian journal of research chemistry. 2012; 5(5):698.
[12] Fegade JD, Bhole RP, Chaudhari RY, Patil VR. Simultaneous estimation of Ofloxacin and Ketorolac tromethamine in ophthalmic dosageform by Reverse phase high performance Liquid chromatography. Asian journal of chemistry, 2009; 21(5):3360-66.
[13] Khusbu BP, Krupa CT, Dilip GM. Stability indicating HPLC method for simultaneous estimation of Ciprofloxacin and Phenylephrine in pharmaceutical dosage forms. Pharmacophore, 2014; 5(2):262-72.
[14] Mukesh M, Richa R, Yertika G, Dharmendra K, Amarendra K. C, Anand G, Ranjith S. Development and validation of RP-HPLC method for the determination of Chlorphentamine maleate and Phenylephrine in pharmaceutical dosage forms. Int journal of comprehensive pharmacy. 2014; 5(05):1-4.
[15] Ananad J, Sellappan M. Development and validation of RP-HPLC method for simultaneous estimation of Citrizine HCl and Phenylephrine HCl in combined dosage form. IAJPS. 2013; 3(5):3863-70.
[16] Mahesh P, Karajane S, Mane A, Bhat A., Shinde P. Analaytical method development and validation of Acetaminophen, Caffeine, Phenylephrine hydrochloride and Dextromethorphine hydrochloride in tablet dosage form by RP-HPLC. Int journal of pharmaceutical science invention. 2013; 2(2):09-15.
[17] Kumar A, Sharma R, Nair A., Saini G. Development and validation of RP-HPLC method for simultaneous estimation of Nimesulide, Phenylephrine Hydrochloride, Chlorphenermine maleate and Caffeine anhydrous in pharmaceutical dosage forms. Acta Pol Pharma. 2012, 69(6):1017-22.
[18] Deepali ST, Gawekar NM, Yadav SS, Mogala AS, Development and validation of RP-HPLC method for simultaneous estimation of Levo-citrizine Dihydrocholride and Phenylephrine in bulk and tablet dosage forms. American Journal of Pharm. tech research. 2012; 2(4):669-676.
[19] Ozan J, Pirol, M, Ozden T, Simultaneous determination of Paracetamol, Phenylephrine hydrochloride, Orolamine citrate and Chlorpheniramine maleate by HPLC in Pharmaceutical dosage forms. E-Journal of chemistry. 2011; 8(3):1275.
[20] Wicharn J, Puanjkaew L. Development of HPTLC method for determination of phenylephrine hydrochloride and bromphenramine maleate tablets. Int journal of pharmacy and pharmaceutical sciences. 2014; 6(6):106-109.
[21] Patil V, Phalke S, Kale S, Patil, R., Vithaldas S. Development and validation of HPTLC method for the simulataneous analysis of Gatifloxacin and Ketorolac tromethamine in eye drops. Journal of chemical and pharmaceutical research. 2013; 5(9):135.
[22] Sejal PG, Mohit G.D, Tejas C.B, Mrinalini C. D. Development and validation of stability indicating HPTLC method for determination of Ofloxacin ketorolac tromethamine in combination. Journal of adv scientific research. 2011; 2(3):77-82.
[23] Swati S, Mashru R. C. Simulatneous determination of phenylephrine hydrochloride and tropicamide in ophthalmic dosage forms with three derivative spectrophotometric methods. Journal of the Chilean chemical society. 2010; 55(4).
[24] Dharal NB, Namita HT, Chilka P, Shah VH, Udhayay UM, Simultaneous estimation of Ketorolac tromethamine and Omeprazole by ultraviolet spectroscopy, Int journal of Research in Pharmacy and science. 2013; 3(2):146.
[25] Jitendra DF, Harshal P.M., Rajesh Y. C, Vijay R. P. Simultaneous spectrophotometric estimation of Ofloxacin and Ketorolac Tromethamine in ophthalmic dosage forms. International Journal of Chem Tech Research. 2009; 1(2):189-194.
[26] Sawant R, Joshi R, Lanke P, Bhangale G. Simultaneous estimation and validation of Paracetamol, Phenylephrine hydrochloride and Chlorpheniramine maleaste in tablets by spectrophotometric method. Asian journal of pharmaceutical research and health care. 2011; 3(2):23-28.
[27] Wankhede SB, Lad KA, Chtilange SS, Development and validation of UV Spectrophotometric methods for simultaneous estimation of Citrizine hydrochloride and phenylephrine hydrochloride in tablets, International journal of pharmaceutical sciences and drug research. 2012; 4(3):222-26.
[28] Raju B, Ramesh M, Borkar RM, Padiya R, Benerjee SK, Srinivas R. Development and validation of liquid chromatography – mass spectrometric method for simultaneous determination of Moxifloxocin and Ketorolac in rat plasma: Application to pharmacokinetic study. Biomedical chromatography. 2012; 26(11):1341-47.
[29] Sheng F, Qian, Z, Ji J, Pei Hu. Determination of phenylephrine in human plasma using ultra performance liquid chromatography-Tandum mass spectrometry, Journal of chromatography B. 2013, 28-32.
Statistics
161 Views | 168 Downloads
How to Cite
1.
Nagarjuna P, Tharun Kumar B, Nalluri BN. Simultaneous Analysis of Phenylephrine HCl and Ketorolac Tromethamine in Bulk and Injectable Formulations by RP-HPLC-PDA Method. JDDT [Internet]. 15Aug.2020 [cited 18May2021];10(4-s):39-5. Available from: https://jddtonline.info/index.php/jddt/article/view/4204