DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF GEMCITABINE HYDROCHLORIDE IN BULK AND POLYMERIC NANOPARTICLES
DOI:
https://doi.org/10.22159/ijap.2017v9i5.19726Keywords:
Gemcitabine Hydrochloride, UV-Visible Spectrophotometer, Correlation coefficient, NilAbstract
Objective: The objective of the present work was to develop and validate a novel, specific, precise and reliable method for estimation of gemcitabine hydrochloride in bulk and polymeric nanoparticles using UV-visible spectroscopy method.
Methods: The UV-Visible spectrophotometric determination was performed with double beam Systronics UV-visible spectrophotometer; model UV-2201 (India). The proposed methods were validated for various parameters like linearity, precision, accuracy, robustness, ruggedness, detection, quantification limits, and formulation analysis as per international conference on harmonization (ICH) guidelines.
Results: The method was based on measurement of absorbance at wavelength maxima i.e. 267.2 nm, λmax of the drug in distilled water, phosphate buffer pH 6.8 and 7.4. The method obeyed Beer Lambert's law in the concentration range of 5-30 µg/ml andR2-value was found to be 0.999. Moreover, the % drug recovered from polymeric nanoparticles was found to be 97.97%.
Conclusion: According to results, the currently developed method shows compliance with acceptance criteria with Q2 (R1) and international conference on harmonization (2005) guidelines, because the % RSD was found to be less than 2%. The developed method was simple, accurate and précised.
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Reddy LH, Couvreur P. Novel approaches to deliver gemcitabine to cancers. Curr Pharm Design 2008;14:1124-37.
Berlin J, Benson AB. Gemcitabine remains the standard of care for pancreatic cancer. Nat Rev: Clin Oncol 2010;7:136-7.
Khaira R, Sharma J, Saini V. Development and characterization of nanoparticles for the delivery of gemcitabine hydrochloride. Hindawi Publishing Corporation Sci World J 2014;4:43-7.
Singh R, Shakya AK, Naik R, Shalan N. Stability-indicating HPLC determination of gemcitabine in pharmaceutical formulations. Int J Anal Chem 2015;12:45-56.
Mini E, Nobilli S, Caciagli C, Landini I. Cellular pharmacology of gemcitabine. Ann Oncol 2006;5:7-12.
Mangamma K, Rao DV, Mohan VS, Prasanna AD. Method development and validation of gemcitabine and irinotecan by RP-HPLC in pharmaceutical formulation. Int J Chem Anal Sci 2012;3:1500-2.
Singh R, Shakya AK, Naik R, Shalan N. Stability-indicating HPLC determination of gemcitabine in pharmaceutical formulations. Int J Anal Chem 2015;5:56-67.
Krishna RM, Ramesh M, Buela M, Kumar TS. Method development and validation for the assay of gemcitabine hydrochloride in pharmaceutical dosage forms by RP-HPLC. Indo Am J Pharm Res 2011;1:189-95.
Reddy MS, Firadous S. Spectrophotometric estimation of gemcitabine HCl in pharmaceutical dosage form via oxidative coupling reaction. Chem Sci Transactions 2015;4:1102-6.
Wang LZ, Yong WP, Soo RA, Lee SC, Soong R, Lee HS, et al. Rapid determination of gemcitabine and its metabolite in human plasma by LC-MS/MS through micro protein precipitation with minimum matrix effect. J Pharm Sci Res 2009;1:23-32.
Annapurna MM, Kumar BSP, Venkatesh B. Validated stability indicating liquid chromatographic method for the determination of gemcitabine hydrochloride in parenterals. Indo Am J Pharm Res 2013;3:23-36.
Wanga G, Jhao G, Chen H, Ding D, Kou L, Kan L, et al. Development and validation of a UPLC-MS/MS assay for the determination of gemcitabine and its L-carnitine ester derivative in rat plasma and its application in oral pharmacokinetics. Asian J Pharm Sci 2017;16:301-4.
Indian Pharmacopoeia. Buffer Solutions 2007;1:240-2.
Kumar BK, Rajan VST, Begum NT. Analytical method development and validation of lidocaine in ointment formulation by UV spectrophotometric method. Int J Pharm Pharm Sci 2012;4:67-74.
Tarkase KN, Admane SS, Sonkhede NG, Shejwal SR. Development and validation of UV-spectrophotometric methods for determination of moxifloxacin HCl in bulk and pharmaceutical formulations. Scholars Res Library Pharm Chem 2012;4:1180-5.
Jain PS, Chaudhari AJ, Patel SA, Patel ZN, Patel DT. Development and validation of the UV spectrophotometric method for determination of terbinafine hydrochloride in bulk and in formulation. Pharm Methods 2011;2:89-95.
Sethuraman S, Radhakrishnan K, Solomonon A. Analytical method development and validation of caffeine in tablet dosage form by using UV-spectroscopy. Int J Novel Trends Pharm Sci 2011;3:90-9.
Balasaheb BG, Balasaheb AK, Subhash TR, Jijabapu K, Sudhakar PS. Development and validation of UV-spectrophotometric method for estimation of dolute gravirsodium in tablet dosage form. Malaysian J Anal Sci 2015;19:67-78.
Pankti D, Kusum M, Mehul P. Development and validation of UV-visible spectrophotometric method for simultaneous estimation of momentasone furoate, hydroquinone and tretinoin from their pharmaceutical dosage form. Int J Pharm Sci 2013;49:296-300.
Dhartarkar PG, Kalamkar RV, Saoji SD, Ingle SG, Atram SC, Game MD. Development and validation of UV spectrophotometric method for estimation of dexibuprofen in bulk and dosage form. Scholars Res Library Pharm Chem 2011;3:361-6.
Kamboj A, Sidana A, Jain UA. Development and validation of UV spectroscopic methods for simultaneous estimation of salbutamol sulphate and doxophylline in combined solid dosage form. Int J Pharm Pharm Sci 2017;9:117-22.
Acharjya SK, Mallick P, Panda P, Kumar KR, Annapurna MM. Spectrophotometric methods for the determination of Letrozole in bulk and pharmaceutical dosage form. J Adv Pharm Technol Res 2010;1:360-70.
Boulanger B, Dewe W, Chiap P, Crommen J, Hubert PH. An analysis of the SFSTP guide on validation of bioanalytical methods: progress and limitations. J Pharm Biomed Anal 2003;32:753-65.
Pourmand M, Azar R, Aghavalijamaat M. Development of validated UV spectrophotometric method for in vitro analysis of sumatriptan in pharmaceutical preparations in comparison with HPLC. Pharm Chem J 2011;44:585–9.
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