RP-HPLC METHOD DEVELOPMENT, VALIDATION, AND QUANTIFICATION OF LORNOXICAM IN LIPID NANOPARTICLE FORMULATIONS
Keywords:Lornoxicam, SLN, NLC, RP-HPLC, Pharmacokinetic
Objective: A simple, reliable, sensitive and validated reversed phase-high performance liquid chromatography (RP-HPLC) method was developed for quantification of lornoxicam (LX) in rat plasma.
Methods: Solid lipid nanoparticle (SLN) and nanostructured lipid carriers (NLC) gel formulations containing lornoxicam were prepared using high-speed homogenization followed by ultra-sonication. Pharmacokinetic study of formulated LX loaded SLN and NLC were performed on Wister albino rats.
Results: The chromatographic separation was performed on hypersil octadecylsilane (ODS)-18 column using a mobile phase of 10 mmol. Phosphate buffer (pH, 4.5) and acetonitrile (65:35 v/v). Elute was monitored at 377 nm with a flow rate of 1 ml/min. Calibration curve was linear over the concentration range of 25.38â€“2046.45 ng/ml. Retention times of LX and internal standard (piroxicam) were 9.3 and 10.2 min, respectively. Maximum plasma drug concentration, the area under the plasma drug concentration versus time curve and elimination half-life for LX loaded SLN gel were found 6381.51Â±971.27ng/ml, 19917.21Â±7111.24 ng h/ml and 7.27Â±1.21h and 8558.13Â±1564.08 ng/ml, 21317.99Â±4568.71 ng/ml and 6.22Â±2.16 h. respectively. In vivo in vitro correlation study, the fraction of drug dissolved from nanoparticle in pH 7.4 was plotted against the fraction of drug absorbed and a linear correlation (R2= 0.9987) was obtained.
Conclusion: A novel simple, simple, sensitive, precise, rapid, accurate, and economical and reliable RP-HPLC method was developed and validated for the estimation of LX in rat plasma.
Bhatt PA, Hamrapurkar PD, Shigwan HS. Development and validation of stability indicating RP-HPLC method for Lornoxicam in bulk drug. Indian J Res Pharm Biotechnol 2013;4:959-66.
Singh B, Saini G, Sharma DNN, Roy SD, Gautam N. Antioxidant activities of two medicinal vegetables: Parkiajavanica and Phlogacanthusthyrsiflorus. Int J Pharm Sci Res 2011;2:102-6.
Hite GH, Foye WO. Analgesic. In: principles of medicinal chemistry. 5th Ed. Boston, Lippincott Wiliams and Wilkins; 2001. p. 771.
MÃ¼ller RH, Lucks JS. Medication vehicles made of solid lipid particles (solid lipid nanospheres-SLN). Eur Patent; 1996.
Kim YH, H Ji, E Y, Park S, Chae S, Lee HS. Liquid chromatography-electrospray lonization tandem mass spectrometric determination of lornoxicam in human plasma. Arch Pharm Res 2007;30:905-10.
Patil KR, Shinde DB, Rane VP, SangshettiJr JN. Stability-indicating LC method for analysis of lornoxicam in the dosage form. Chromatographia 2009;69:1001-5.
Yadav S, Jagtap AS, Rao JR. Simultaneous determination of paracetamol, Lornoxicam and Chlorzoxazone in tablets by high-performance thin layer chromatography. Pharm Chem 2012;4:1798-802.
Sivasubramanian L, Lakshmi KS, Tintu T. Simultaneous spectrophotometric estimation of Paracetamol and Lornoxicam in tablet dosage form. Int J Pharm Sci 2010;2:166-8.
Kim YH, Ji HY, Park ES, Chae SW, Lee HS. Liquid chromatography-electrospray ionization tandem mass spectrometric determination of Lornoxicam in Human Plasma. Arch Pharm Res 2007;30:905-10.
Dasgupta S, Ghosh SK, Ray S, Mazumder B. Solid lipid nanoparticles (SLNs) gels for topical delivery of lornoxicam in vitro and in vivo evaluation. Curr Drug Delivery 2013;10:656â€“66.
Han F, Yin R, Che X, Yuan J, Cui Y, Yin H, et al. Nanostructured lipid carriers (NLC) based topical gel of flurbiprofen: design, characterization and in vivo evaluation. Int J Pharm 2012;439:349â€“57.
Pani NR, Acharya S, Patra S. Development and validation of RP-HPLC method for quantification of glipizide in biological macromolecules. Int J Biol Macromol 2014;65:65-71.
Pani NR, Nath LK, Singh AV, Mahapatra SK. Development and validation of analytical method for the estimation of nateglinide in rat plasma. J Pharm Anal 2012;2:492â€“8.
Singh AV, Nath LK, Pani NR. Development and validation of analytical method for the estimation of lamivudine in rat plasma. J Pharm Anal 2011;1:251â€“7.
Bhattacharya SS, Banerjeeb S, Ghosh AK, Chattopadhyay P, Verma A, Ghosh A. An RP-HPLC method for quantification of diclofenac sodium released from biological macromolecules. Int J Biol Macromol 2013;58:354â€“9.
Hubert PH, Chiap P, Crommen J. The SFSTP guide on the chromatographic for drug bioanalysis: from the Washington conference to the laboratory. Anal Chim Acta 1999;391:135â€“48.
Bourne DWA. In: Banker GS, Rhodes CD. Eds. Modern Pharmaceutics (Drugs and the Pharmaceutical Sciences). 4th Vol. 121. Marcel Dekker Inc, NewYork; 2002. p. 67â€“92.
Wagner JG. Biopharmaceutics and Relevant Pharmacokinetics EDN first. Drug Intelligence Publishers, Illinois; 1971.
US Department of Health and Human Services, Guidance for the Industry, USFDA, CDER. Rockville; 2000.
Aher KB, Bhavar GB, Joshi HP. Rapid RP-HPLC method for quantitative determination of Lornoxicam in bulk and pharmaceutical formulations. Int J ChemTech Res 2011;3:1220-4.
Ravisankar P, Devala GR. Development and validation of RP-HPLC method for determination of levamisole in bulk and dosage form. Asian J Pharm Clin Res 2013;6:169-73.