DEVELOPMENT AND VALIDATION OF NOVEL SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF PIOGLITAZONE AND METFORMIN IN BULK AND FIXED DOSAGE FORMS BY AREA UNDER CURVE AND DUAL WAVELENGTH MODE

Objective: Two simple, accurate and reproducible spectrophotometric methods have been developed and validated for simultaneous estimation of metformin (MET) and pioglitazone (PIO) in bulk and tablet dosage forms. Methods: (1) Area under curve method (Area calculation): The proposed area under the curve method involves measurement of area at selected wavelength ranges. Two wavelength ranges were selected 228-238 nm and 265-275 nm for estimation of MET and PIO respectively. (2) Dual wavelength method: In the dual-wavelength method, two wavelengths were selected for each drug in a way so that the difference in absorbance is zero for another drug. PIO shows equal absorbance at 235 and 266 nm, where the difference in absorbance was measured for determination of MET. Similarly, the difference in absorbance at 216 and 241.5 nm was measured for determination of MET. Results: Linearity range for MET and PIO is 2-10 μg/ml and 10-50 μg/ml at respective selected wavelengths. Accuracy and precision studies were carried out, and results were satisfactory. The proposed methods have been validated as per ICH guidelines and successfully applied to the estimation of MET and PIO in their combined tablet dosage form. Conclusion: The developed methods are simple, precise, rugged and economical. The utility of the methods has been demonstrated by analysis of commercially available formulations. Keywords: Metformin, Pioglitazone, Area under curve method, Dual wavelength metho

DIFFERENCE SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF MOXIFLOXACIN AND CEFIXIME TRIHYDRATE IN BULK AND COMBINED DOSAGE FORM

Objective: To develop rapid, accurate, reproducible, validated and economical difference spectroscopy method for the simultaneous determination of moxifloxacin (MFN) and cefixime (CEF) in tablet dosage forms.Methods: The method comprised the measurement of the absorbance of a solution of the tablet extract in 0.1 M NaOH relative to that of an equimolar solution in 0.1 M HC1 at 254 nm for MFN and 292 nm for CEF. The presence of identical isosbestic points for pure drug solutions and tablet extracts indicated the non-interference of excipients in the absorption at these wavelengths.Results: The method was found to be linear over the concentration range of 10-50 μg/ml for CEF and 4-20 μg/ml for MFN. Accuracy was found to be in the range of 99.91-101.18%. Relative standard deviation for precision and intermediate precision was found to be less than 2%. The developed method was successfully applied for the simultaneous estimation of Moxifloxacin and Cefixime in tablet formulation. The results obtained from the validation experiments prove that the developed method is suitable for routine analysis.Conclusion: This method is simple, selective, linear, precise, and accurate and sensitive hence can be successfully employed for the routine quality control of dosage forms containing both the drugs in pharmaceutical industries.Â

Synthesis, molecular properties, toxicity and biological evaluation of some new substituted imidazolidine derivatives in search of potent anti-inflammatory agents

The aim of this study was to design and synthesize pharmaceutical agents containing imidazolidine heterocyclic ring in the hope of developing potent, safe and orally active anti-inflammatory agents. A number of substituted-imidazolidine derivatives (3a–k) were synthesized starting from ethylene diamine and aromatic aldehydes. The imidazolidine derivatives (3a–k) were investigated for their anticipated anti-inflammatory, and analgesic activity in Wistar albino rats and Swiss albino mice, respectively. Bioactivity score, molecular and pharmacokinetic properties of the imidazolidine derivatives were calculated by online computer software programs viz. Molinspiration and Osiris property explorer. The results of biological testing indicated that among the synthesized compounds only three imidazolidine derivatives namely 4-[1,3-Bis(2,6-dichlorobenzyl)-2-imidazolidinyl]phenyl-diethylamine (3g), 4-[1,3-Bis(3-hydroxy-4-methoxybenzyl)-2-imidazolidinyl]phenyl-diethylamine (3i) and 4-(1,3-Bis(4-methoxybenzyl)-4-methylimidazolidin-2-yl)-phenyl-diethylamine (3j) possess promising anti-inflammatory and analgesic actions. Additionally these derivatives displayed superior GI safety profile (low severity index) with respect to the positive control, Indomethacin. All synthesized compounds showed promising bioactivity score for drug targets by Molinspiration software. Almost all the compounds were predicted to have very low toxicity risk by Osiris online software. Compound number (3i) emerged as a potential candidate for further research as it obeyed Lipinski’s rule of five for drug likeness, exhibited promising biological activity in-vivo and showed no risk of toxicity in computer aided screening. Keywords: Imidazolidine, Indomethacin, Anti-inflammatory, Analgesi