Azithromycin

The present study was designed to develop simple accurate, precise, reproducible and validating of a stability indicating reverse phase high performance liquid chromatographic (RP-HPLC) method for the simultaneous estimation of azithromycin, ornidazole and fluconazole in bulk and its pharmaceutical dosage forms. Chromatographic separation of the three drugs was performed on a Phenomenex C18 column (250X4.6mm 5μm) as stationary phase with a mobile phase comprising of 20mM potassium dihydrogen phosphate : Acetonitrile (pH 4.8) in the ratio 30:70% v/v at a flow rate of 1ml/min and peak monitored at 254nm using PDA detector. The retention time of azithromycin, fluconazole, ornidazole and procaine hydrochloride (internal standard) was Rt1-2.8, Rt2-5.0, Rt3-6.3 and Rt-3.8minutes respectively. The linearity of azithromycin, fluconazole and ornidazole were in the range of 20-100μg/ml, 3-15μg/ml and 15-75μg/ml with an internal standard, procaine hydrochloride 5µg/ml respectively. The accuracy of the method was found to be 98-102% and %RSD was found to be less than 2% indicating high degree of accuracy and precision of the proposed HPLC method. The limit of detection for azithromycin, fluconazole and ornidazole was found to be 0.34, 2.80 and 0.76μg/ml respectively whereas, the limit of quantification was found to be 1.05, 8.6 and 2.31μg/ml respectively. Forced degradation studies were conducted to know the stability of the drug samples under various stress conditions like acid, base, peroxide and photolytic degradation according to ICH guidelines. Results are validated statistically as per ICH guidelines.

A simple, economic, rapid, high range and accurate stability indicating RP-HPLC method was development for simultaneous estimation of Azithromycin and Ambroxol Hydrochloride in their combined tablet dosage form. This method was carried out by using Isocratic peak HPLC instrument with kromasil C-18 Column (250 mm X 4.6mm,5um) with mobile phase consisting a mixture of Methanol: Acetonitrile: Phosphate buffer in the ratio of 70:20:10 (v/v), at a flow rate of 1.1 ml/min with UV detection at 221nm . The retention time for Azithromycin and Ambroxol Hydrochloride are 9.08 and 5.39min respectively. Suitability, specificity, linearity, accuracy, precision, stability, and sensitivity of this method for the quantitative determination of the drugs were proved by validation in accordance with the requirements laid down by International Conference on Harmonization (ICH) Q2 (R1) guidelines. To establish stability indicating nature of the LC method, forced degradation of drug substances was performed under stress conditions like thermal, oxidation, peroxide, UV light, acid and base hydrolysis) The limit of quantification (L.O.Q) for Azithromycin and Ambroxol Hydrochloride are found to be 0.70ug/ml 1.00ug/ml.Then the limit of detection (L.O.D) for Azithromycin and Ambroxol Hydrochloride are found to be 0.15ug/ml and 0.3ug/ml respectively. The results of the study showed that the proposed method is reliable and robust and can be used as quality control tool for the estimation of these drugs in combined pharmaceutical solid dosage forms.

  The task of developing immediate release tablet is accomplished by using a suitable diluents and super-disintegrants. Faster disintegration of the tablet administrated orally minimizes absorption time and improves its bioavailability in less time. Immediate Release tablet of Antibiotic drug is formulated using dry granulation using super disintegrant croscarmellose sodium. Azithromycin is Antibiotic drug is used to treat STDs due to Chlamydia and gonorrhea, community-acquired pneumonia, pelvic inflammatory disease, pediatric otitis media and pharyngitis, and Mycobacterium avium complex (MAC) in patients with advanced HIV disease. One of the important studies included in the present investigation is of study on process parameter effect on performance of the Immediate Release tablets. The effect of selected process parameters on critical properties of immediate release (IR) tablets were studied, like effect of disintegration time, friability, dissolution profile.   Key words: Immediate release, Azithromycin, Croscarmellose sodium