Quantification and stability aspects of Luliconazole in bulk and pharmaceutical dosage forms by UV spectroscopy

Two simple and economical UV spectroscopic methods were developed for the estimation of Luliconazole in creams. The drug showed maximum absorption at 294 nm, both in 0.1N HCl and phosphate buffer (pH 2.0) in the fundamental spectra (D0). The same spectra were derivatized into first derivative (D1) and the dA/dλ was measured at 315 nm in 0.1N HCl and 317 nm in phosphate buffer (pH 2.0). In both the methods the drug obeyed Beer-Lambert’s law in the concentration range of 2-30 μg/mL in 0.1N HCl and 10-30 μg/mL in phosphate buffer (pH 2.0). The linear regression equations were calculated to be y = 0.0504x + 0.0102 (R2 = 0.9991) for D0 and y = 0.0025x + 0.0002 (R2 = 0.9991) for D1 in 0.1N HCl, y = 0.0637x + 0.0181 (R2 = 0.999) for D0 and y = 0.0025x + 0.0006 (R2 = 0.999) for D1 in phosphate buffer (pH 2.0). An acceptable recovery in the range of 98 ± 0.01 – 102 ± 0.001 % indicates accuracy as well as non-interference from excipients in the present method. The intraday and inter day precision results were within 2 % RSD indicating the preciseness of the methods. The methods were applied for quantification of Luliconazole in marketed creams and the assay was obtained as 98.53 % w/w against the label claim. The methods were also applied to study the stability aspects of the drug in a variety of conditions like acid, base and oxidative stress along with thermal and photolytic stress conditions. The drug showed altered absorbance in basic and photolysis conditions. The methods were validated statistically as per the ICH guidelines. Keywords: Luliconazole, UV spectroscopy, Stability, Validation, ICH

New Spectrophotometric Methods for the Quantification of an Anti-Peptic Ulcer Drug in Bulk and Tablets

Two simple, economical and reproducible fundamental and derivative UV spectrophotometric methods were developed and validated for determination of Famotidine in bulk and dosage form. Famotidine showed maximum absorption at 281 nm in phosphate buffer pH 7.5 while it has 282 nm as its absorption maxima in borate buffer pH 9.0. The linearity was determined in the concentration range of 30-80 μg/mL (r2 as 0.9993 & 0.9987) and 10-60 µg/mL (r2 as 0.9991 & 0.9995) for the fundamental and derivative methods in phosphate and borate buffers. The developed methods were validated as per ICH guidelines. Recovery studies gave satisfactory results indicating that none of the major additives/excipients interfered with the assay method. This method may be useful for routine laboratory analysis of famotidine

UV Spectrophotometric Method Development and Validation for Determination of an Antifungal Agent in Bulk and Capsules

A sensitive zero order UV spectroscopic method (Method A) and a first order derivative method (Method B) has been developed and validated for the determination of Itraconazole in formulations using phosphate buffer (pH 2.0). The drug showed maximum absorbance at 255nm (Method A) and amplitude was measured in the range of 245 nm-270 nm (Method B). Thedrug obeyed linearity in the range of 5–60 μg/mL. The present methods were validated as per International Conference on Harmonization guidelines. Percent recovery for Itraconazole in the range of 98- 101.66 % indicates accuracy and % RSD < 1.95 indicates precision of the methods. These methods can beconveniently used for the quality control analysis of Itraconazole in capsules without any interference from the excipients

Estimation of bilastine and montelukast by stability indicating liquid chromatographic method in pure binary mixture and their marketed tablets

The main objective of the current work is to develop and validate a new RP-HPLC method for estimation of Bilastine and Montelukast in bulk and in their combined tablets. A good separation of both analytes in various types solutions was attained by using a Ascentis C18 (150 x 4.6mm, 2.6µ) column with a solvent or mobile phase of 0.1% OPA: acetonitrile (50:50 v/v) at a flow rate of 1ml/min and a detection wavelength of 230nm. To test the stability of the analytes, the drug substance was put in an environment with a lot of stress, such as hydrolysis with acid and base, peroxide oxidation, and thermal degradation. At at 2.25min and 2.78 min, Bilastine and Montelukast were eluted with isocratic elution. The method is expected to show a linear response from 2.5 to 15µg/ml for Bilastine and from 5 to 30 µg/ml for Montelukast. Bilastine's LOD and LOQ were establishe to be 0.1and 0.31µg/ml, while Montelukast's were 0.3 and 0.91µg/ml. From the Bilastine and Montelukast peaks, the degradant peaks that were made were easy to tell apart. The method was very sensitive, accurate, cost-effective, and showed stability.&nbsp