DEVELOPMENT AND VALIDATION OF ULTRAVIOLET SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF MEBHYDROLINE NAPADISYLATE IN TABLET PREPARATIONS


Nerdy Nerdy

Abstract


Objective : Mebhydrolin Napadisylate is classified as an antihistamine drug classes used to treat allergies. One of the quality requirements for drug preparation was active compound levels must meet the requirements as stated in the Pharmacopoeia or other standard books. The purpose of this study was to validate an ultraviolet spectrophotometric method of determination of Mebhydrolin Napadisylate in the tablet preparation available in the market.

Methods : Solvents used are hydrochloric acid (HCl) 0.1 N in methanol and sodium hydroxide (NaOH) 0.1 N in methanol for determination of Mebhydrolin Napadisylate and has not been reported. The ultraviolet spectrophotometric method used in the determination of Mebhydrolin Napadisylate will be conducted validation which includes: accuracy, precision, linearity, range, limit of detection (LOD) and limit of quantitation (LOQ).

Results : Measurements were made at a maximum wavelength (λmax) of Mebhydrolin Napadisylate 287 nm. Results of ultraviolet spectrophotometric method validation in determination of Mebhydrolin Napadisylate in tablet preparation; accuracy, precision, linearity, range, limit of detection (LOD), and limit of quantitation (LOQ) meet the requirements of validation tests for methods of analysis. The obtained results of the determination of Mebhydrolin Napadisylate levels in tablet preparation with a branded name on the market meet the general requirements of tablet preparation.

Conclusion : Ultraviolet spectrophotometric method of Mebhydrolin Napadisylate determination in tablet preparation meets the requirements of validation tests for methods of analysis. The determination of Mebhydrolin Napadisylate levels in tablet preparation meets the general requirements of tablet preparation.

Keywords : Development, Validation, Ultraviolet Spectrophotometric, Mebhydroline Napadisylate

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References


Nerdy. In Silico Docking of Chemical Compounds from Roselle Calyces (Hibiscus Sabdariffa L.) as Antidiabetic. Int J ChemTech Res 2015;7(1):148-152.

Nerdy. In Silico Study of Sesquiterpene Lactone Compounds from South Africa Leaves (Vernonia amygdalina Del.) as Antimalarial and Anticancer. Int J PharmTech Res 2015;7(1):47-53.

Nerdy, Putra EDP, Haro G, Harahap U. In Silico Screening of Hesperetin and Naringenin Ester Derivatives as Anticancer against P-Glycoprotein. Int J Pharm Pharm Sci 2014;7(2):485-488.

Nerdy, Putra EDP, Haro G, Harahap U. In Silico Screening of Hesperetin and Naringenin Ester Derivatives as Anticancer Against Phosphoinositide 3-Kinase. Int J PharmTech Res 2016;9(6):388-394.

Karsono, Patilaya P, Azisah N, Nerdy. Comparison of Antimicrobial Activity of Red Betel (Piper crocatum Ruiz & Pav) Leaves Nanoparticle and Powder Ethanolic Extract Against Methicillin Resistant Staphylococcus aureus. Int J PharmTech Res 2015;8(4):696-701.

Masfria, Haro G, Nerdy, Mierza V, Wahyuni HS, Permata YM. Antimicrobials Activity, Antioxidants Activity and Analysis of Active Extract Chemical Compounds Content of Moringa (Moringa oleifera Lam.) Leaf. Int J PharmTech Res 2016;9(11):110-120.

Nazliniwaty, Karsono, Zebua NF, Nerdy. Ethanol Extract Grapefruit Peel (Citrus maxima Murr.) Gel Formulations with Gelling Agent Durian Seed Gum and Carboxy Methyl Cellulose. Pharma Chem 2016;8(20):207-213.

Nazliniwaty, Karsono, Zebua NF, Nerdy. Antioxidant Activity and Antiaging Gel Formulation Grapefruit Peel (Citrus maxima Merr.) Ethanolic Extract. Pharm Lett 2016;8(20):84-94.

Criado PR, Criado RFJ, Maruta CW, Filho CDM. Histamine, Histamine Receptors and Antihistamines: New Concepts. An Bras Dermatol 2010;85(2):195-210.

Nerdy, Putra EDP, Tjahjono DH. Development and Validation of High Performance Liquid Chromatography Mass Spectrometry Method for Determination of Rifampicin, Isoniazid and Pyrazinamide from Tablet Preparation. Int J PharmTech Res 2014;6(5):1647-1664.

Wulandari L, Yuwono M, Indrayanto G. Densitometric Determination of Mebhydrolin Napadisylate in Tablets. J Planar Chromatogr 2012;25(1):60-64

Wulandari L. Determination and Validation of Mebhydroline Napadisylate in Tablets by High Performance Liquid Chromatography. Indo J Chem 2008;8(3):377-379.

Zagorodny CL, Vasyuk SA. Development Spectrophotometric Method of Determination Mebhydrolin in Dosage Forms. Aktual Pitann à Farm Med Nauki Prakt 2015;4(17):33-38.

Rohman A, Gandjar IG. Pharmaceutical Chenistry Analysis. 1st Edition. Yogyakarta: Pustaka Pelajar; 2007.

Moffat AC, Osselton MD, Widdop B. Clarke‘s Analysis Of Drug And Poisons. 3rd Edition. London: Pharmaceutical Press; 2004.

Syed MR, Hashmi S, Naik JB. Ultraviolet Spectrophotometric Method Development and Validation for Determination of Paroxetine Hydrochloride in Pharmaceutical Dosage Form. Int J Pharm Pharm Sci 2010;2(2):43-45.

Pourghazi K, Khoshhesab XM., Golpayeganizadeh A, Shapouri MR, Afrouzi H. Spectrophotometric Determination of Cetirizine and Montelukast in Prepared Formulations. Int J Pharm Pharm Sci 2011;3(2):128-130.

Dibbern HW, Müller RM, Wirbitzki E. Ultraviolet and Infrared Spectra. Germany: Cantor Verlag Aulendorf; 2002

Épshtein NA. Validation of High Performance Liquid Chromatography Techniques for Pharmaceutical Analysis. Pharm Chem J 2004;38(4):212-228.

Indonesia Health Ministry. Indonesia Pharmacopoeia. 5th Edition. Jakarta: Indonesia Health Ministry; 2014.

Pavia DL, Lampman GM, Kriz GS. Introduction to Spectroscopy. Philadelphia: Saunders Golden Sunburst Series; 1979.

Miller JM. Chromatography Concepts and Contrast. 2nd Edition. New York: Wiley Interscience; 2005.

Harmita. Method Validation Implementation Guidelines and Calculations. Jakarta: Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Indonesia; 2004.

Rohman A. Chromatography for Drug Analysis. 1st Edition. Yogyakarta. Graha Ilmu; 2009.

Indonesia Health Ministry. Indonesia Pharmacopoeia. 4th Edition. Jakarta: Indonesia Health Ministry; 1995.

Moffat AC, Osselton MD, Widdop B. Clarke‘s Analysis Of Drug And Poisons. 3rd Edition. London: Pharmaceutical Press; 2004.

Ermer J. Method Validation in Pharmaceutical Analysis. Weinheim: Wiley Verlag; 2005.




About this article

Title

DEVELOPMENT AND VALIDATION OF ULTRAVIOLET SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF MEBHYDROLINE NAPADISYLATE IN TABLET PREPARATIONS

DOI

10.22159/ajpcr.2017.v10i4.16879

Date

01-04-2017

Additional Links

Manuscript Submission

Journal

Asian Journal of Pharmaceutical and Clinical Research
Vol 10 Issue 4 April 2017 Page: 367-372

Print ISSN

0974-2441

Online ISSN

2455-3891

Statistics

69 Views | 94 Downloads

Authors & Affiliations

Nerdy Nerdy
Akademi Farmasi Yayasan Tenaga Pembangunan Arjuna, Pintubosi, Laguboti, Toba Samosir, Sumatera Utara, Indonesia, 22381
Indonesia


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