• V.Divya
• P.Niharika
• G.Gowtham
• Dr.P.Lalshmaiah

Abstract Validation is defined as “Establishing documented evidence which provide high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristic.Performed a simple, specific and precise high performance thin layer chromatographic method and validated for estimation of Bepotastine as bulk drug and in ophthalmic solution. The chromatographic development was carried out on pre coated silica gel 60 F254 aluminium plates using mixture of Methanol: Water: Glacial Acetic acid (8:2:0.2 v/v/v) as mobile phase and densitometric evaluation of band was carried out at 247 nm using Camag TLC Scanner-3 with win CAT 1.4.3 version software. The Rf value of drug was found to be 0.37 ± 0.01. The method was validated with respect to linearity, accuracy, precision and robustness. The calibration curve was found to be linear over a range of 200 to 1200 ng/ band. The method has been successfully applied for the analysis of drug in ophthalmic solutions. The % assay (Mean ± S.D.) was found to be 100.51 ± 1.01 for Bepotastinehydrochloride. Thus the proposed HPTLC method was found to provide a faster and cost effective quantitative control for routine analysis of Bepotastine hydrochloride as bulk drug and in ophthalmic solutions. Validation is a means to prove that an equipment or process actually performs as per design or requirement. This is achieved by measuring any attribute that is possible to quantify. The objective of the analytical procedure should be clearly understood since this will govern the validation characteristics, which need to be evaluated. Typical validation characteristics that should be considered are listed below. HPLC is a type of liquid chromatography that employs a liquid mobile phase and a very finely divided stationary phase. In order to obtain satisfactory flow rate liquid must be pressurized to a few thousands of pounds per square inch. The rate of distribution of drugs between stationary and mobile phase is controlled by diffusion process, if diffusion is minimized, a faster and effective separation can be achieved. The technique of high performance liquid chromatography is so called because of its improved performance when compared to classical column chromatography.

Key words: Bepotastine, RP-HPLC, Validation, chromatography, Sampling

"Method Development and Validation of new RP-HPLC Method for the Estimation of Bepotastine in Pharmaceutical Dosage Form", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 4, page no.232-253, April-2019, Available :http://www.jetir.org/papers/JETIR1904534.pdf

"Method Development and Validation of new RP-HPLC Method for the Estimation of Bepotastine in Pharmaceutical Dosage Form", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 4, page no. pp232-253, April-2019, Available at : http://www.jetir.org/papers/JETIR1904534.pdf