ISSN : 0975-9492
CODEN : IJPSQQ





INTERNATIONAL JOURNAL OF PHARMA SCIENCES AND RESEARCH


Open Access

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ABSTRACT

Title : DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF MUPIROCIN AND MOMETASONE FUROATE IN TOPICAL FORMULATION BY RP-HPLC
Authors : Arti P. Parmar, Dr.Dilip G.Maheshwari
Keywords : Mometasone Furoate, Mupirocin, Method development, Validation, RP HPLC method.
Issue Date : April 2015
Abstract :
Purpose: To develop simple, precise, rapid RP-HPLC (Reverse-phase High Performance Liquid Chromatography) method for estimation of marketed combination formulation of Mupirocin and Mometasone Furoate. Methods: The Chromatographic separation was achieved on a reversed-phase Phenomenax-luna C18 (250 x 4.6mm, 5 m) column using a mobile phase consisting of acetonitrile : Sodium dihydrogen phosphate buffer (pH 6.8) (70:30 v/v) at a flow rate of 1 mL/min and UV detection at 240 nm. Developed methods were validated according to ICH Q2 (R1) guidelines. The methods were found to be linear between the range of 10 - 60 g/ml for Mupirocin and 1 6 g/ml for Mometasone Furoate. Results: An intra-day precision for Mupirocin was found to be 0.6788% - 0.9820% and for Mometasone Furoate 0.6758%- 0.7532%, inter-day precision for Mupirocin was found to be 0.9775% - 1.1277% for Mometasone Furoate 0.9114% - 1.0765%. Accuracy was determined by recovery studies and showed % recovery between 98 to 102%. Conclusions: A simple, accurate and precise HPLC method was developed and validated for the routine analysis of Mometasone Furoate and Mupirocin in ointment topical formulation. The results make known that the proposed method could be successfully useful for the routine analysis and quality control of pharmaceutical dosage forms containing Mometasone Furoate and Mupirocin. NOVELTY OF THE WORK - The proposed HPLC method was validated as per ICH guidelines. The drug was extracted from an ointment and there is no any interference of excipients was founded. The results of the recovery studies performed show the high degree of accuracy of the proposed method, hence proposed method will useful to routine analysis of Mometasone Furoate and Mupirocin.
Page(s) : 758-766
ISSN : 0975-9492
Source : Vol. 6, No.4