DEVELOPMENT OF QUANTITATIVE METHOD OF TULOBUTEROL HYDROCHLORIDE IN RAT PLASMA: VALIDATION AND APPLICATION TO PRECLINICAL PHARMACOKINETICS

AYESHA NAZ; CVS SUBRAHMANYAM; SHYAM SUNDER RACHAMALLA

doi:10.22159/ijap.2023v15i6.49118

Authors

AYESHA NAZ Department of Pharmacy, University College of Technology, Osmania University, Hyderabad, India https://orcid.org/0000-0001-9908-4512
CVS SUBRAHMANYAM Gokaraju Rangaraju College of Pharmacy, Osmania University, Hyderabad, India
SHYAM SUNDER RACHAMALLA Department of Pharmacy, University College of Technology, Osmania University, Hyderabad, India

DOI:

https://doi.org/10.22159/ijap.2023v15i6.49118

Keywords:

Chronic obstructive pulmonary disease (COPD), HPLC, Protein precipitation method, Tulobuterol hydrochloride

Abstract

Objective: A robust, simple, accurate, rapid, and selective bioanalytical high-performance liquid chromatography (HPLC) method was established and validated to determine the tulobuterol hydrochloride in rat plasma.

Methods: The protein precipitation method deproteinated analyte from rat plasma using acetone. The analysis of tulobuterol hydrochloride from rat plasma was accomplished using a mobile phase comprising of methanol: potassium dihydrogen orthophosphate buffer (0.05M; pH 4.0) in 90:10 (v/v) ratio run at 1.0 ml/min flow rate. Separation was carried on BDS hypersil C18 column (4.6 mm × 250 mm; 5 µ) at ambient temperature employing a 996 photodiode array (PDA) detector at 228 nm.

Results: The linearity model was exhibited from 100-500 ng/ml with a good correlation of 0.999. Tulobuterol hydrochloride was efficiently separated at a retention time of 7.281 min. The percent recovery rate was between 100.21-100.46 %. The accuracy, precision, robustness, and ruggedness study showed relative standard deviation (%RSD) was within 2% (acceptable limit), and that revealed the method was efficient, precise, reliable, and reproducible.

Conclusion: A simple, accurate, suitable method to quantitate tulobuterol hydrochloride in rat plasma was established using HPLC employed with a PDA detector that overcomes the increased cost for analysis. The developed method was successfully validated in rat plasma.

Downloads

Download data is not yet available.

References

Kulkarni PN, Jadhav CK, Dodake Supekar AMD, Gill CH. The quality by design approach for simultaneous determination of fluticasone propionate and salmeterol xinafoate. Int J App Pharm. 2022;12(4):70-6. doi: 10.22159/ijap.2020v12i4.37574.

Eff ARY. Incidence of hypertension in asthma patients who treated with beta-2 agonists bronchodilators. Int J Pharm Pharm Sci. 2017;9(4):181-4. doi: 10.22159/ijpps.2017v9i4.17013.

McCall KL, Raehl C, Nelson S, Haase K, Fike DS. Evaluation of pharmacy students’ blood pressure and heart rate measurement skills after completion of a patient assessment course. Am J Pharm Educ. 2007;71(1):1. doi: 10.5688/aj710101, PMID 17429501.

Yamaya M, Nishimura H, Nadine L, Kubo H, Ryoichi N. Tulobuterol inhibits rhinovirus infection in primary cultures of human tracheal epithelial cells. Physiol Rep. 2013 Aug;1(3):e00041. doi: 10.1002/phy2.41, PMID 24303127.

Ichikawa M, Kodama Y, Yoshimi K, Shiota S, Kotajima M, Nakajyo M. Effects of transdermal tulobuterol on dyspnea and respiratory function during exercise in patients with chronic obstructive pulmonary disease. J Thorac Dis. 2015 Apr;7(4):687-96. doi: 10.3978/j.issn.2072-1439.2015.04.22, PMID 25973235.

Shindoh C, Murakami Y, Shishido R, Sasaki K, Nishio T, Miura M. Tulobuterol patch maintains diaphragm muscle contractility for over twenty-four hours in a mouse model of sepsis. Tohoku J Exp Med. 2009 Aug;218(4):271-8. doi: 10.1620/tjem.218.271, PMID 19638730.

Ichikawa T, Sugiura. Long-term safety, efficacy, and patient acceptability of the tulobuterol patch. Research and Reports in Transdermal Drug Delivery. 2013;2:9-18. doi: 10.2147/RRTD.S34031.

Japanese pharmacopoeia XVIII Ed. The ministry of health, labor and welfare; 2021. p. 1883.

Shindoh C, Tsushima R, Shindoh Y, Tamura G. Transdermal treatment with tulobuterol increases isometric contractile properties of diaphragm muscle in mice. Tohoku J Exp Med. 2007 Jul;212(3):309-17. doi: 10.1620/tjem.212.309, PMID 17592218.

Chandini Ruchita B, Mathrusri Annapurna M. Analytical techniques for the assay of tulobuterol–a review. Act Scie Pharma 2021;5(9):37-40. doi: 10.31080/ASPS.2021.05.0780.

Jaiswal R, Wadetwar R. Development and validation of RP-HPLC method for estimation of clinidipine in rat plasma. Int J Pharm Pharm Sci. 2022;14(10):32-7.

Dasgupta S, Dey S, Pal P, Mazumder B. RP-HPLC method development, validation, and quantification of lornoxicam in lipid nanoparticle formulations. Int J Pharm Pharm Sci. 2016;8(11):152-8. doi: 10.22159/ijpps.2016v8i11.14256.

Cheng L, Hao G, Chen X, Zhang Y, Zhang Y, Dong R. Quantification of tulobuterol, a selective β2 adrenergic agonist, in human plasma by liquid chromatography-tandem quadrupole mass spectrometry. J Chin Pharm Sci. 2016;25(7):526-53. doi: 10.5246/jcps.2016.07.058.

Han X, Liu R, Ji L, Hui M, Li Q, Fang L. Determination of tulobuterol in rat plasma using a liquid chromatography-tandem mass spectrometry method and its application to a pharmacokinetic study of tulobuterol patch. J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Jan 1;1008:108-14. doi: 10.1016/j.jchromb.2015.11.017, PMID 26638035.

Xu F, Zhang Z, Tian Y, Jiao H, Liang J, Gong G. High-performance liquid chromatography-electrospray ionization mass spectrometry determination of tulobuterol in rabbit’s plasma. J Pharm Biomed Anal. 2005 Feb 7;37(1):187-93. doi: 10.1016/j.jpba.2004.09.052, PMID 15664761.

Matsumura K, Kubo O, Sakashita T, Adachi Y, Kato H, Watanabe K. Quantitative determination of tulobuterol and its metabolites in human urine by mass fragmentography. J Chromatogr. 1981 Jan 2;222(1):53-60. doi: 10.1016/s0378-4347(00)81032-4, PMID 7217327.

Thienpont LM, Verhaeghe PG, De Leenheer AP. Measurement of tulobuterol in human plasma by capillary gas chromatography and selected ion monitoring detection. Biomed Environ Mass Spectrom. 1987 Nov;14(11):613-6. doi: 10.1002/bms.1200141107, PMID 2962665.

Wong EYL, Loh GOK, Goh CZ, Tan YTF, Ng SSM, Law KB. Sample preparation and quantification of polar drug, allopurinol, in human plasma using LCMSMS. Eur J Mass Spectrom (Chichester). 2022;28(1-2):35-46. doi: 10.1177/14690667221105837, PMID 35668610.

Deshpande MM, Kasture VS, Mohan M, Chavan MJ. Bioanalytical method development and validation: a review. In: Ince M, Ince OK, editors. Recent Advances in Analytical Chemistry. London, UK: Intech Open; 2019.

Veeresham C, Srinivas C, Qureshi HK, Shyam P. Enantioselective RP-UFLC method for the simultaneous estimation of sitagliptin (STG) enantiomers (R and S) in the racemic mixture and their pharmacokinetic assessment in male wistar rats. IJPSDR 2022;14(1):54-61. doi: 10.25004/IJPSDR.2022.140108.

Sura RS, Cvs S, Rachamalla SS. Bioanalytical RP-HPLC method development and validation of clopidogrel bisulfate in wistar rat plasma and its application to pharmacokinetic study. Int J App Pharm. 2022;14(1):106-11. doi: 10.22159/ijap.2022v14i1.43328.

Gopalan D, Patil PH, Jagadish PC, Kini SG, Alex AT, Udupa N. QbD-driven HPLC method for the quantification of rivastigmine in rat plasma and brain for pharmacokinetics study. J Appl Pharm Sci. 2022;12(06):56-67. doi: 10.7324/JAPS.2022.120606.

Kharkar PB, Talkar SS, Patravale VB. A rapid and sensitive bio analytical RP-HPLC method for detection of docetaxel: development and validation. Indian J Pharm Educ Res. 2017;51(4S):s729-34. doi: 10.5530/ijper.51.4s.105.

Thompson M, Ellison SLR, Wood R. Harmonized guidelines for single-laboratory validation of methods of analysis (IUPAC technical report). Pure Appl Chem. 2002;74(5):835-55. doi: 10.1351/pac200274050835.

Rao TN. Validation of analytical methods. In: Mark Stauffer T, editor. Calibration and validation of Analytical Method. London: In. Tech Open; 2018.

Veeraswami B, Naveen VMK. Development and validation of RP-HPLC method for the estimation of dolutegravir and rilpivirine in bulk and pharmaceutical dosage form and its application to rat plasma. Asian J Pharm Clin Res 18;12(2):261-7.

Sandhya P, Subrahmanyam CVS, Patnaik KR. Bioanalytical method development and validation of valsartan in rabbit plasma. Int J Pharm. 2015;5(4):1360-4.

Reagan Shaw S, Nihal M, Ahmad N. Dose translation from animal to human studies revisited. FASEB J. 2008 Mar;22(3):659-61. doi: 10.1096/fj.07-9574LSF, PMID 17942826.

Arumugam K, Chamallamudi MR, Mallayasamy SR, Mullangi R, Ganesan S, Jamadar L. High performance liquid chromatographic fluorescence detection method for the quantification of rivastigmine in rat plasma and brain: application to preclinical pharmacokinetic studies in rats. J Young Pharm. 2011;3(4):315-21. doi: 10.4103/0975-1483.90244, PMID 22224039.

Mane V, Killedar S, More H, Gaikwad A, Tare H. A novel RP-HPLC gradient elution technique for bioanalytical method development and validation for estimating gallic acid in wistar rat plasma. Int J App Pharm. 2023;15(2):153-60. doi: 10.22159/ijap.2023v15i2.47278.

Sonar P, Shaikh K, Harer S. Development and validation of novel RP-HPLC-DAD method for quantification of lapatinib ditosylate in the newer nano-liposome formulation: a quality by design (qbd) approach. Int J App Pharm. 2022;14(6):239-50. doi: 10.22159/ijap.2022v14i6.45750.

Afroz F, Moni F, Sharmin S, Rony SR, Afroz F, Masum S. Efficacy of liquid-liquid extraction and protein precipitation methods in serum sample preparation for quantification of fexofenadine in human serum. Acta Pharm Sci. 2022;60(3):273-93. doi: 10.23893/1307-2080.APS.6018.