The stability of mobile phase was also determined by freshly prepared solutions of BHT at 24 hrs interval for 5 days. The mobile was not changed during the study. The variability in the estimation of BHT was within �� 10% during solution normally stability and mobile phase stability. The results from solution stability and mobile phase stability experiments confirmed that mobile phase was stable up to 5 days and also sample solution and standard solutions were stable up to 5 days on bench top. Assay result and method application To check the application of the method three different types of paricalcitol HG capsules formulations were selected where BHT concentration were different. These each sample were analyzed three times as per above-mentioned method and results are found satisfactory which is summarized Table 7.

Table 7 Assay results of RP-LC method CONCLUSIONS A simple and efficient reverse-phase HPLC method was developed and validated for quantitative analysis of Butylated Hydroxy toluene in paricalcitol capsule pharmaceutical dosage forms. The method found to be precise, accurate, linear, robust and rugged during validation. Satisfactory results were obtained from the validation of the method. The method is can be used for routine analysis of production samples and to check the stability of the BHT in paricalcitol capsules.[17] ACKNOWLEDGMENT The authors are thankful to the management of Dr. Reddy’s Laboratories Ltd., Hyderabad for providing facilities to carry out this work. Footnotes Source of Support: Dr. Reddy’s Laboratories Ltd., Hyderabad Conflict of Interest: No conflict of interest.

Chemically, lafutidine is 2-[(2-furyl methyl) sulfinyl]-N-(2z-4-[4-(piperridin-1yl methyl) pyridin-2-yl] oxy but-2-en-1-yl) acetamide [Figure 1].[1] It is a H2 receptor antagonist and is reported to show potent and long lasting antagonisms of histamine H2 receptor mediated effect. It is effective agonist the esophageal lesions induced by acid reflux through inhibition of acid secretion.[2] Analysis is an important component in the formulation development of any drug molecule. It becomes essential to develop a simple, sensitive, accurate, precise, reproducible method for the estimation of drug samples. Our main concern is development and validation[1] of UV spectrophotometric method as per ICH guideline.

[3] Figure 1 Chemical structure of lafutidine Earlier publications have described HPLC[4] and LC�CMS[5] methods for quantification of lafutidine in human plasma and pharmaceutical dosage form. However, these methods involve arduous sample preparation and long chromatographic rum times for biological samples. Entinostat So far to our present knowledge, no UV spectrophotometric analytical method is available in literature for analyzing lafutidine in pharmaceutical dosage form or as bulk drug sample.