*Corresponding Author Address: Manisha S. Phoujdar, Department Quality Assurance Techniques, STES’s, Sinhgad College of Pharmacy, Vadgaon (Bk.), Pune- 411041, Maharashtra, India; Email- mphoujdar@hotmail.com World Journal of Pharmaceutical Sciences ISSN (Print): 2321-3310; ISSN (Online): 2321-3086 Published by Atom and Cell Publishers © All Rights Reserved Available online at: http://www.wjpsonline.org/ Original Article Development and validation of HPTLC method for determination of betamethasone valerate in API and pharmaceutical dosage form Neha Sharad Sinnarkar and Manisha S. Phoujdar* Department Quality Assurance Techniques, STES’s, Sinhgad College of Pharmacy, Vadgaon (Bk.), Pune- 411041, Maharashtra, India. Received: 19-03-2017 / Revised: 24-04-2017 / Accepted: 26-04-2017 / Published: 27-04-2017 ABSTRACT The aim of present work was to develop a simple and sensitive, HPTLC for the quantitative estimation of Betamethasone Valerate in its single component cream formulations (20 g). Betamethasone Valerate was chromatographed on silica Gel 60 F254 TLC plate using Ethyl Acetate: n- Heptane: Toluene: Ethanol (5.1:2.4:1.2:0.3 v/v/v/v) as mobile phase. Betamethasone Valerate in methanol scanned by Camag TLC scanner 4 with UV visible detector over wavelength range 200 to 400 nm, showed Rf value of 0.34 at wavelength 246 nm and selected for further studies. The method was validated in terms of linearity (1-9 μg/ml), precision (intra- day variation 1.40, inter-day variation 1.71), accuracy (84 to 96%) and specificity. The limit of detection and limit of quantification for Betamethasone Valerate were found to be 0.97 μg/spot and 2.96 μg/spot, respectively . It can be concluded from the results that the proposed method was accurate, precise and consistent the determination of Betamethasone Valerate in dosage form. This method was validated as per ICH guideline Q2 (R1). Results suggest that this method can be used for routine estimation of Betamethasone Valerate in bulk and pharmaceutical dosage forms. Key Words: Betamethasone Valerate, Toluene, Ethanol, n-heptane, Ethyl acetate, HPTLC. INTRODUCTION Betamethasone Valerate is a corticosteroid. It works by modifying the body's immune response to various conditions and decreasing inflammation. Betamethasone Valerate is official in Indian Pharmacopoeia. Literature survey reveals that some methods have been developed for their determination by HPLC, HPTLC or spectrophotometry either alone or in combination. However, overall cost of analysis of reported HPTLC method is more. In this view, an economical HPTLC method has been developed for estimation of Bethamethasone Valerate in pharmaceutical dosage form. MATERIALS AND METHODS Bethamethasone Valerate standard was provided by GSK pharmaceuticals, Nasik, India. “Betnovate 20 g” skin cream were procured from local market. AR grade of solvents used for this study were purchased from Merck Pvt. Ltd, Mumbai. Preparation of standard solution: A standard stock solution of Betamethasone Valerate was prepared by dissolving 10 mg of standard API in 10 ml of methanol to get concentration of 1000 μg/ml. This solution was further diluted to get 100 μg/ml solution of Bethamethasone Valerate as working standard. Fig. 1: Chemical Structure of Bethamethasone Valerate Selection of wavelength for Detection: The working standard of Bethamethasone Valerate in methanol was scanned by Camag TLC scanner 4 with UV-visible detector over wavelength range 200 to 400 nm. Wavelength 246 nm was selected for further studies. (Figure 2).