Objective:The vagina has been studied as a favorable site for the local and systemic delivery of drugs, for female associated conditions. Vaginal preparations, although generally perceived as safer most still associated with number of problems including multiple days of dosing, dripping, leakage and messiness, causing discomfort to users and expulsion due to the self-cleansing action of the vaginal tract. These limitations lead to poor patient compliance and failure of the desired therapeutic effects. For efficient vaginal delivery of drugs, the delivery system should reside at the site of infection for a prolonged period of time. In situ gel formulation which combines advantages of both gels and solution so that an accurate dose can be administered with ease. These formulations remain in solution state before administration and transforms to gel after administration in to vaginal cavity.Material and Methods:In these formulations we prepared clindamycin loaded hydroxypropyl methycellulose (0.1%) (bioadhesive) and gellan gum (ion activated gelling polymer) based in situ gel system for vaginal application. NaCl (0.9%) was added as an isotonic agent. The developed formulation was characterized for various in vitro parameters such as clarity, refractive index, pH, viscosity, drug release profile, statistical release kinetics, bioadhesive force, and microbial efficacy along with stability studies. To simulate vaginal conditions, synthetic membrane (cellophane hydrated with modified simulated vaginal fluid) was used as model membranes.Results and Discussion:The developed formulation was found to be nonirritant, bioadhesive with good retention properties. Formulations have satisfactory appearance, clarity and drug content in the range 98.1-101%. Refractive index of the gel is ranging from 1.335 to 1.337, proofing the transparency of gel. Furthermore, formulation displayed 33.3% cumulative drug release after 2 h. 67.4% after 6 h and 98.9% after 12 h.Conclusion:Developed formulation should be stable. Hence, formulation is thus a viable alternative to conventional vaginal dosage forms.

This paper describes simple, sensitive, precise, specific, and stability-indicating high-performance thin-layer chromatographic method for the determination of dutasteride (DUTA) in bulk and tablet formulation. Validation was carried out in compliance with International Conference on Harmonization guidelines. The thin-layer chromatographic method employed aluminium plates precoated with silica gel G60F254 as stationary phase. The solvent system consisted of toluene/methanol/triethylamine (9 : 2 : 1, v/v/v). This solvent system was found to give compact spots for dutasteride with value 0.71 ± 0.01. Densitometric analysis of DUTA was carried out in the absorbance mode at 274 nm. Linear regression analysis showed good linearity () with respect to peak area in the concentration range of 200–3000 ng per spot. The method was validated for precision, accuracy, specificity, and robustness. Pure drug was subjected to acid and alkali hydrolysis, oxidation, photo degradation, dry heat and wet heat treatment. The drug underwent degradation under acidic, basic, oxidative, and wet heat conditions. The degraded products were well separated from the pure drug. Statistical analysis proved that the method is reproducible and selective for estimation of DUTA in bulk and tablets. As the method could effectively separate the drugs from their degradation products, it can be employed as a stability indicating method.

A new, simple, rapid, selective, precise and accurate gradient RP-HPLC method has been developed for simultaneous estimation of Ciprofloxacin and Phenylephrine Hydrochloride in combined dosage form. The separation was achieved by using Thermic Hypersil C column (250 mm x 4.6 mm, 5 µm particle size) coupled with a guard column of same material, in mobile phase Acetonitrile: Methanol: Phosphate Buffer pH 6 (10: 65: 25, v/v/v). The flow rate was 1.0 ml/min and the separated drugs were detected using UV detector at the wavelength of 220 nm. The analysis was performed at room temperature (37 ± 2 ºC). The retention time of Ciprofloxacin and Phenylephrine Hydrochloride was noted to be 6.63 and 4.49 min, respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The calibration curves were linear (r2 > 0.9980) over a concentration range from 0.5 – 4.0 μg/ml and 2.0 – 5.5 μg/ml for Ciprofloxacin and Phenylephrine Hydrochloride, respectively. The relative standard deviation (RSD) was < 2.0% and the mean recovery was 100.51 ± 0.34 and 100.81 ± 0.80 for Ciprofloxacin and Phenylephrine Hydro-chloride, respectively. The proposed method was found to be accurate, reproducible, and consistent. It was successfully applied for the analysis of these drugs in marketed formulations and could be effectively used for the routine analysis of formulations containing any one of the above drugs, or a combination, without any alteration in the chromatographic conditions.

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A simple, precise and sensitive UV spectrophotometric method has been developed for the estimation of Remogliflozin etabonate in bulk and pharmaceutical dosage Form. Remogliflozin etabonate shows Maximum Absorbance at 229nm. Beer’s law was obeyed in range of 2-10µg/ml. The correlation coefficient was found to be 0.9990. The result of interday and intraday precision shows standard deviation ranging from 0.050% - 0.254% and 0.058% - 0.258% for three concentration and three replicates. The Percentage recovery was found to be in the range of 98.94% - 99.86%. The LOD and LOQ were found to be 0.037µg/ml and 0.113µg/ml respectively. The purposed method was novel and successfully applied for the determination of Remogliflozin Etabonate in Tablet Dosage Form. The method was successfully validated according to ICH guidelines.