Journal of Pharmacy Research Vol.9 Issue 1.January 2015 Lobhe G. A.et al. / Journal of Pharmacy Research 2015,9(1),5-9 5-9 Research Article ISSN: 0974-6943 Available online through www.jpronline.info *Corresponding author. Lobhe G. A. Department of Pharmaceutical Chemistry, VJSM’s Vishal Institute of Pharmaceutical Education & Research, Ale, Pune (Dt.), M. S.(412411), India. A validated new stability indicating densitometric method for quantitative analysis of glipizide in tablets Lobhe G. A.* 1 , Dr. Shah Amol 2 , Dr. Singhvi Indrajeet 3 1 Department of Pharmaceutical Chemistry, VJSM’s Vishal Institute of Pharmaceutical Education & Research, Ale, Pune (Dt.), M. S.(412411), India. 2 STCOP, Shirur,Pune 3 Pacific Academy of Higher Education &Research University, Udaipur-313024 (Rajasthan) India Received on:26-11-2014; Revised on: 19-12-2014; Accepted on:14-01-2015 ABSTRACT A sensitive, precise, specific, linear, and stability-indicating high performance thin-layer chromatographic (HPTLC) method has been estab- lished and validated for quantitative analysis of one of the antidiabetic agents, the sulfonylurease glipizide in active pharmaceutical ingredi- ent (API) and in tablet formulation, using toluene: methanol (8:2; v/v) as mobile phase. Chromatographic separation was achieved on precoated silica gel 60F 254 plates with 0.2 mm thickness . Detection and quantification were performed by classical densitometry using a UV detector at 230 nm. Compact spots were obtained for glipizide (R F 0.35± 0.02, mean ± SD). Calibration plots were constructed in the range 100- 700 ng per band and were linear with good calibration coefficients (r =0.9997 ±0.01, mean ± SD) for glipizide. The limit of detection and quantification were 100 and 300 ng per spot for glipizide. Glipizide was subjected to the International Conference on Harmonization (ICH) prescribed hydrolytic (acid, base, and neutral), oxidative, photolytic, and thermal stress conditions. Among all the above mentioned condi- tions, the drug was found to be susceptible to some stress conditions. However, the degradation products were well resolved from the pure drugs with significantly different R F values. KEY WORDS: HPTLC, Quantitative Analysis, Validation, stability indicating procedure, Glipizide, Tablets. 1. INTRODUCTION All sulfonylureas increase insulin secretion and enhance insulin ac- tivity. They stimulate insulin release for pancreatic B cells, with more pronounced action in presence of glucose. Even with the availability of many newer anti-diabetic medications,sulfonylureas remain attractive from the standpoint of cost, general tolerability and mecha- nism of action [1] . Glipizide is the second generation sulfonylureas because of enhanced solubility and greater selective binding capacity [2] . A few thin-layer chromatographic and densitometric methods have been established for identification and quantification of glipizide. These methods are characterized by high sensitivity and high recov- ery. However, they are not fully validated especially I relation to sta- bility-indicating properties [3-5] . Therefore, the objective of the work discussed in this paper was to develop the fully validated, stability – indicating and simple densitometric method for analysis of glipizide (Fig.1.) in tablets, because such method could be useful for quality control of glipizide for some pharmaceutical purposes as simpler and clearly less expensive than HPLC method. Figure 1. Structure of Glipizide 2. EXPERIMENTAL 2.1. Samples and Solutions Glipizide was from glenmark pharmaceuticals pvt ltd., Mumbai. Tolu- ene, acetone and methanol for chromatography were from E. Merck (Germany). Stock solution (1 mg mL -1 ) was prepared by dissolving the appropriate amounts of the drug in methanol. 2.2. Chromatography Chromatography was performed on 10 × 10 cm 2 aluminum HPTLC plates precoated with 0.2 mm layers of silica gel (E.Merck, Darmstadt, Germany; supplied by Merck India, Mumbai, India). Before chroma-