Spectrophotometric Determination of Alendronate Sodium by using Sodium-1,2-Naphthoquinone-4-Sulphonate

DOI:

https://doi.org/10.37285/ijpsn.2011.4.4.7

Authors

  • Sagar Suman Panda
  • Ravi Kumar B V V
  • D Patanaik

Abstract

A simple, precise and accurate spectrophotometric method was developed for analysis of the osteoporesis drug alendronate sodium (ALS). The method is based on reaction of the drug with sodium-1,2-naphthoquinone-4-sulphonate (NQS) in presence of alkali to form a brown colored complex giving absorption maximum at 525 nm. The drug obeyed Beer’s law in the range of 5-70 µg/ml with a correlation coefficient of 0.999. The LOD and LOQ values are 1.7 µg/ml and 5.0 µg/ml, respectively. The average recoveries for recovery study were found to be in the range of 99.37%-100.46%. The R.S.D. values for intraday and inter-day precision were found to be 0.48 and 0.62, respectively. The optimized assay conditions were applied successfully for determination of ALS in pharmaceutical dosage forms. No interference was observed from the excipients present in the dosage form. The method is statistically validated as per the ICH requirements.

 

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Keywords:

bisphosphonates, Alendronate, ICH, spectrophotometry, sodium-1,2-naphthoquinone-4-sulphonate, chromogenic reagent.

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Published

2012-02-29

How to Cite

1.
Panda SS, B V V RK, Patanaik D. Spectrophotometric Determination of Alendronate Sodium by using Sodium-1,2-Naphthoquinone-4-Sulphonate. Scopus Indexed [Internet]. 2012 Feb. 29 [cited 2024 Jun. 20];4(4):1563-8. Available from: https://www.ijpsnonline.com/index.php/ijpsn/article/view/466

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Research Articles

References

Al Deeba SK and Hamdan II (2004).Spectroscopic and HPLC methods for determination of alendronate in tablets and urine.Talanta 64:695-702.

Ashraf MM,Nasr KY,Ibrahim DA, and Tarek A (2009). Selective Spectrophotometric and Spectrofluorometric Methods for the Determination of Amantadine Hydrochloride in Capsules and Plasma via Derivatization with 1, 2Naphthoquinone-4-sulphonate. Int J Anal Chem 10:1155-1162.

Chen T,Zhao W,Hu HJ, and Lu TL (2010). RP-HPLC analysis of hydrophobic alendronate amidated derivatives.J Liq Chromatogr Relat Technol 33:349-361.

Darwish,IA (2005). Kinetic spectrophotometric methods for determination of trimetazidine dihydrochloride. Anal Chim Acta 551:222-231.

de Haro Moreno A,Pezza HR, and Pezza LR (2004). Potentiometric determination of alendronate in pharmaceutical formulations. Chem Anal 49:351-357.

Hasani M,Yaghoubi L, and Abdollahi H (2007). A kinetic spectrophotometric method for simultaneous determination of glycine and lysine by artificial neural networks. Anal Biochem 365:74-81.

Hu HJ,Lu TL,Chen T,Ma YF, and Chen Y (2009). Determination of alendronate sodium by ion-pair reversed phase HPLC with refractive index detection. Fenxi Shiyanshi 28:43-46.

International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2005). Guideline on Validation of Analytical Procedures: Text and Methodology Q2 (R1), Harmonized Tripartite Guideline, Geneva, Switzerland.

Jeong Y,Park J,Jin G, and Park JS (2011). Spectrofluorimetric determination of alendronate by conjugataion with the rhodamine B sulfonyl group. Bull Korean Chem Soc 32:1777-1780.

Job P(1964) Advanced Physicochemical Experiments, 2nd Edition,Oliner and Boyd, Edinburgh, UK, pp.54.

Kang HS,Hwang SJ,Park JS, and Kim CK (2006). HPLC method validation and pharmacokinetic study of alendronate sodium in human urine with fluorescence detection. J Liq Chromatogr Relat Technol. 29:1589-1600.

Koba M,Koba K, and Przyborowski L (2008). Application of UV derivative spectrophotometry for determination of some bisphosphonate drugs in pharmaceutical formulations. Acta Pol Pharm 65:289-294.

Li Q-M,Li J, and Yang ZJ (2007). Study of the sensitization of tetradecyl benzyl dimethyl ammonium chloride for spectrophotometric determination of dopamine hydrochloride using sodium-1,2-naphthoquinone-4-sulfonate as the chemical derivative chromogenic reagent. Anal Chim Acta.583:147-152.

Li Q-M, and Yang Z-J (2007). Spectrophotometric determination of aminomethyl benzoic acid using sodium-1,2-naphthoquinone-4-sulphonate as the chemical derivative chromogenic reagent. Spectrochim Acta,Part A. 66:656-661.

Liu GX, Lu TL,Sheng P , Qi YF, and Mei QB (2008). RP-HPLC determination of alendronate sodium in rat plasma. Yaowu Fenxi Zazhi 28:2118-2121.

Meng J,Meng Q, and Zheng L (2010). A simple and rapid high-performance liquid chromatography method for determination of alendronate sodium in beagle dog plasma with application to preclinical pharmacokinetic study. Biomed Chromatogr 24:169-173.

Prinsloo PJJ and Hosking DJ (2006). Alendronate sodium in the management of osteoporosis.Ther Clin Risk Manag 2:235-249.

Prutthiwanasan B, and Suntornsuk L (2010). Rapid analysis of alkylphosphonate drugs by capillary zone electrophoresis using indirect ultraviolet detection. J Sep Sci 33:228-234.

Sibel fi A, Sema CA, Sedef K, and Murat F (2003). The determination of alendronate sodium in microparticular systems by high performance liquid chromatography. FABAD J Pharm Sci 28: 183-192.

Svididritskii EP,Jiang M Sh ,Il’in VI,Dyn’kov DI,Pirogov AV, and Shpigun OA (2010). The determination of alendronate ion and certain inorganic ions using capillary electrophoresis. Moscow Univ Chem Bull 65:42-48.

Tsai EW,Ip DP, and Brooks MA (1992). Determination of alendronate in pharmaceutical dosage formulations by ion chromatography with conductivity detection. J Chromatgr A.596:217-224.

Vachal P,Hale JJ,Lu Z,Streckfuss EC,Mills SG,MacCoss M,Yin DH,Algayer K,Manser K,Kesisoglou F,Ghosh S and Alani LL (2006). Synthesis and study of alendronate derivatives as potential prodrugs of alendronate sodium for the treatment of low bone density and osteoporosis. J Med Chem 49:3060-3063.

Xu L,Wang H, and XiaoY (2004). Spectrophotometric determination of ampicillin sodium in pharmaceutical products using sodium-1,2-naphthoquinone-4-sulfonic as the chromogenic reagent. Spectrochim Acta, Part A 60:3007-3012.

Yun MH, and Kwon KI (2006). High performance liquid chromatography method for determining alendronate sodium in human plasma by detecting fluorescence:application to a pharmacokinetic study in humans. J Pharm Biomed Anal 40:168-172.

Yun MH,Woo JS, and Kwon KI (2006). Bioequivalence and pharmacokinetics of 70mg alendronate sodium by measuring alendronate in plasma. Arch Pharm Res 29:328-332.

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