DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF LAFUTIDINE IN BULK AND PHARMACEUTICAL DOSAGE FORM


Ritesh Kumar, Amrish Chandra, Swati Gupta, Pawan Kumar Gautam

Abstract


Objective: The objectives of the present research was to develop a simple, precise, economical, accurate, reproducible and sensitive method for the quantitative estimation of lafutidine in bulk and its pharmaceutical dosage forms by Ultra Violet (UV) absorption spectrophotometry.

Methods: The method uses 0.1 N HCl, pH 1.20 as a solvent of choice for the quantitative estimation of lafutidine in bulk and its tablets dosage form by UV absorption spectrophotometry at a wavelength of 290 nm. The method was validated for parameters like linearity, range, precision, Limit of Detection (LOD), Limit of Quantification (LOQ), accuracy, recovery and stability of the analyte.

Results: Lafutidine exhibited absorbance maxima at 290 nm in 0.1 N HCl, pH 1.20 solvent. The developed method was validated as per the ICH validation guidelines. Beer’s law was obeyed in range of 0-30 µg/ml with r2= 0.9997. The LOD and LOQ values of lafutidine were found to be 0.545 µg/ml and 1.654 µg/ml respectively. The mean % recovery for the developed method was found to be in the range of 99.25 to 99.45 % respectively for the marketed dosage forms. The developed method was also found to be robust.

Conclusion: The developed method was found suitable for the routine quantitative analysis of lafutidinein bulk and pharmaceutical dosage form. It was also concluded that developed UV spectrophotometry method was accurate, precise, linear, reproducible, robust and sensitive.


Keywords


Lafutidine, ICH, Validation, Assay, UV spectrophotometry, SGF, Range

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About this article

Title

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ESTIMATION OF LAFUTIDINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Keywords

Lafutidine, ICH, Validation, Assay, UV spectrophotometry, SGF, Range

DOI

10.22159/ijap.2017v9i6.21943

Date

08-11-2017

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 9, Issue 6 (Oct-Nov), 2017 Page: 75-79

Online ISSN

0975-7058

Statistics

36 Views | 9 Downloads

Authors & Affiliations

Ritesh Kumar
Department of Pharmacy, IFTM University, Moradabad, 244102, Uttar Pradesh, India
India

Amrish Chandra
Amity Institute of Pharmacy, Amity University, Noida, 201313, Uttar Pradesh, India

Swati Gupta
Department of Pharmaceutics, Dr. K N Modi Institute of Pharmaceutical Education and Research, Modinagar, 201201, Uttar Pradesh, India

Pawan Kumar Gautam
Department of Pharmacy, S. N. Medical College, Agra, 282002, Uttar Pradesh, India


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