Method Development and Validation for the Simultaneous Estimation of Diphenhydramine, Ephedrine, Noscapaine, Glycerol Glycolate in Bulk and in Tablets by Using RP-HPLC | Chapter 1 | Novel Aspects on Pharmaceutical Research Vol. 1

 The present survey highlights the happening and validation of a reverse phase souped up liquid chromatographic (RP-HPLC) method to measure DH, ED, NP and GG simultaneously all-inclusive and in fixed dosage form, Noscof. Noscof Tablet is used to control and relieve syndromes of allergy, allergic reaction to pollen, common cold, asthma, low ancestry pressure, prostate cancer, heart failure, diarrhea, type of encephalitis, Meningitis, Reye's syndrome, and dry cough. RP-HPLC for the concurrent estimation of DH, ED, NP and GG was done on an Altima C18 pillar with 0.01M KH2PO4 safeguard (PH 3.5) and Acetonitrile (50%, v/v) as mobile time at 0.8 ml/min flow rate in an isocratic mode at 260 nm and form was validated in accordance with ICH guidelines. The pill sample solution was subjected to various stress conditions utilizing ICH strategy like hydrolytic depravity i.e. Neutral medium- with water purified by distillation, Alkaline medium– with 2N NaOH and Acidic medium– accompanying 2N HCl, oxidative degradation accompanying 10% H2O2, photo degradation by revealing to UV light and dry heat degradation by revealing to 105oC.Using the above established chromatographic conditions, sharp peaks were obtained for ED, NP, DH and GG accompanying retention period of 3.272 min, 4.098 brief time period, 5.467 min and 6.783 min individually.  Good regression coefficients principles were obtained in the range of 2-12 µg/ml for ED, 3.75-22.5 µg/ml for NP, 3.125-18.75 µg/ml for DH and 25-150 µg/ml for GG. The QLs were 0.181 µg/ml, 0.187 µg/ml, 0.246 µg/ml and 1.114 µg/ml for ED, NP, DH and GG, individually. The values of confirmation parameters are within the agreeable limits of ICH guidelines. The ED, NP, DH and GG had proved higher portion of degradation in acidic medium and less allotment of degradation in impartial medium. The peaks of degradants did remove imposed controls on a system with the peaks of analytes. ED, NP, DH and GG were assessed accompanying good percentage of assay (about 100%) and low allotment relative standard deviation (<2%) in Noscof tablets using the projected method.The RP-HPLC form developed was substantiated and was found to be appropriate for the quantification of ED, NP, DH and GG together in bulk in addition to in tablet dosage form.

Author(s) Details:

Pulagurtha Bhaskararao,
Aditya Pharmacy College, Surampalem, Kakinada, Andhra Pradesh, India and Jawaharlal Nehru Technological University Kakinada, Andhra Pradesh, India.

Kontham Venkataramanapa Raju,
Aditya Pharmacy College, Surampalem, Kakinada, Andhra Pradesh, India and Jawaharlal Nehru Technological University Kakinada, Andhra Pradesh, India.

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