Stability Indicating Rp-Hplc Method Development and Validation for Simultaneous Quantification of Antihistaminic & Anti-Asthmatic Drug in Bulk and Tablet Dosage Form

The main aim of the present research work was to study Prospective process validation of Vildagliptin 50 mg uncoated tablet which is an Antidiabatic drug. Quality cannot be adequately assured by in- process and finished product testing but it should be built into the various stages of manufacturing process. The Process Validation was carried out for three consecutive batches manufacturing process, equipment, formula and validation criteria. The critical parameters involved in dry mixing, granulation, drying, Pre - lubrication, lubrication and compression stages, were identified, monitored and found in state of control. All the in process parameters and process variables were checked and found well within acceptance criteria. Loss on drying is not more than 2.5 % at 105 °C for 4 minutes by halogen moisture balance, Uniformity of Blend (By HPLC) was found within 10.0 % of the mean of the results and the % RSD not more than 5.0 %, Assay (By HPLC) for drug content is 47.5 mg to 52.5 mg was within the acceptable limit for the samples which were collected after lubrication stage (95.0 % to 105.0 %). The % LOD for dried granules after drying found out within 1.0 %w/w to 3.0 % w/w, In process testing for compression (Avg. wt. 20 Tab.: 194 mg to 206 mg; hardness 3.00-9.00 kg/cm2, thickness 2.95-3.55 mm; diameter 7.90-8.30 mm; friability NMT 1.0 % w/w; Disintegration time NMT 15 minutes and uniformity of dosage units found within acceptance value not more than 15.0 %).