The idea for writing this basic HPLC book was probably born during the project sanctioned by University Grants Commission - Pune. This book was written as an updated reference guide for busy laboratory analysts and researchers. Topics covered include HPLC operation, method development and validation aspects. This book can serve as a supplementary text for students pursuing a career in analytical chemistry. It describes basic theories and terminologies for the novice and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. A reader with a science degree and a basic understanding of chemistry is assumed.

To formulate and evaluate time dependent pulsatile drug delivery system of Montelukast sodium to deliver the drug with biological rhythm of asthma after predetermined lag time 5:30 hours. In preliminary study, The core tablet of Montelukast sodium was prepared by using direct compression method containing SSG, Croscarmellose sodium, Crospovidone, MCC and Starcap1500 to obtain fast disintegrating tablet for the selection of super disintegrating agent. PVAP, CAP and Ratio of Eudragit L 100: Eudragit S 100 was used as pH dependent polymer for coating the core tablets. Total 9 batches were formulated as per 32 full factorial design applied to check the effect of polymer ratio (Eudragit L 100: Eudragit S 100) and the effect of % weight gain on dependent variable lag time PRTs. These formulations were evaluated for physical parameters of tablet, drug -excipient compatibility study, lag time of rupture of PRTs and in-vitro drug release study. PDDS of Montelukast Sodium formulated using Croscarmellose sodium as super disintegrant and Eudragit L 100 and Eudragit S 100 as a coating polymers. Formulation M7 can provide site specific delivery with sigmoidal drug release.

Oral drug delivery is the most widely utilized route of administration among the entire route that has been explored for the systemic delivery of drug via various pharmaceutical products of different dosage form. The conventional tablet seems to be most popular because of its ease of transportation and low manufacturing cost as compare to others but poor patient compliance with whom experienced swallowing difficulties. In response to this mouth dissolving drug delivery system (MDDs) were developed as an alternative to tablet, capsule and syrup. A variety of MDDs like Mouth dissolving tablets (MDTs) and Mouth dissolving films (MDFs) were commercialized. This book describes the design and development of sildenafil citrate mouth dissolving film. As sildenafil citrate is a widely utilized drug for erectile dysfunction. This produced mouth dissolving film prepared by newer polymer Kollicoat protect and showed the good alternative for the other mouth dissolving film former, specially HPMC. Stevioside a natural sweetener used and showed the potency to mask the bitter taste of sildenafil citrate. Hence, MDF of sildenafil citrate provide good alternate to other available dosage form.

Manufacturing area with new equipment having high capacity compared to previous one (Production Line) i.e. FBD, RMG, Co Mill and Container Mixer. Manufacturing of Metformin ER 500mg tablets is planned to do in new area with new equipment. As the size and capacity of the equipments are bigger than previous equipments, batch size of Metformin ER tablets is increasing from 0.4 mio to 0.6 mio. As the production in new area and new equipment, qualification of area, equipment, water and air was carried out as per qualification protocol. Now, further the process of optimization was performed for Metformin ER tablets by identifying the critical Process parameters i.e. standardization batch (BATCH I). Before going to start process validation, one standardization batch was taken, where the process optimization of critical parameter like mixing speed, mixing time, lubrication time was carried out; fast, 15 min, 15 min respectively the results for that. Three process validation batches (PV-1, PV-2 and PV-3) of commercial batch size were taken in which Manufacturing Process, critical parameters, Validation status of equipments & Validation criteria's were considered.

Itopride, a novel prokinetic agent is unique and different from the available prokinetics because of its dual mode of action and lack of significant drug interaction potential. Itopride is a newly developed prokinetic agent, which enhances gastric motility through both anti-dopaminergic and anti-acetylcholinesterage actions. It is best candidate for Gastro Esophageal Reflux Disease. Itopride 50mg can be given thrice in a day for Treatment of GERD. By developing the sustain release formulation of Itopride hydrochloride, the frequency of drug can be reduce to once only to obtain good therapeutic response. The prepared formulation is usually taken on an empty stomach about an hour before meals. Sustained release tablet of Itopride Hydrochloride was prepared by using combination of HPMC grade as matrix forming material. The influence of amount of Hydroxypropyl Methylcellulose K15M and Hydroxypropyl Methylcellulose K100M on release of Itopride hydrochloride was studied using Central composite design. The optimized Formulation FB7 had given prolonged drug release up to 24 hr. It also had desired drug release kinetics and it was found to be stable after 1 month at accelerated conditions.

In the present investigation, solid dispersion of olanzapine has been prepared to improve its solubility. Further, using solid dispersion, mouth dissolving tablet was prepared to overcome the problem of swallowing. A Simplex Lattice design was applied using three factors, i.e. superdisintegrants like croscarmellose sodium(X1) crospovidone(X2), and sodium starch glycolate(X3) in tablet formulation. Disintegration time, Wetting time, Water absorption, T50 (Time required to 50% drug release) and Q10 (percentage of drug released in 10 min.) taken as responses. Solid dispersion showed significant enhancement in solubility of olanzapine. For mouth dissolving tablet, batch containing 5% croscarmellose sodium alone had minimum disintegration time (44 sec.) and faster drug release(T50: 40 sec) compared to other batches.

To develop sustained release matrix tablet of Tramadol HCl that deliver drug for 24 hr and to be taken once in a day. Drug having high solubility and relatively shorter half-life suggests its suitability for an extended formulation. If it is formulated by conventional tablets, it will require multiple daily administrations which ultimately results into inconveniency to the patients and possibility of reduced compliance with prescribed therapy. Also fluctuation in plasma drug concentration leads to exaggerated side effects, this all limitations can be minimized by adopting extended release formulation. To reduce the frequency of administration and to improve the patient compliance, Once in a day sustained release formulation is desirable. It describes the influence of the concentration of HPMC K4M, HPMC K15M and HPMC K100M on Tramadol HCl sustained release formulations using box-behnken design.These Polymers were selected as an independent variables. Drug release after 8 hr, 12 hr and 16 hr were selected as a dependent variables. Optimized formulation found by similarity and dissimilarity factor follow zero order kinetic with non-fickian diffusion as a drug release mechanism.